Colon Cancer Stage IIPhase 3NCT06490536
The Sagittarius Trial
A Phase 3 study testing Oxaliplatin, Capecitabine and Folinic acid in people with Colon Cancer Stage II and Colon Cancer Stage III, run by IFOM ETS - The AIRC Institute of Molecular Oncology at 26 sites in 3 countries.
Trial summary
Background \& Rationale: Colon cancer is a leading cause of cancer deaths, with a high recurrence rate in stage II high-risk and stage III patients due to undetectable micro-metastases. Liquid biopsy (LB) detects residual cancer DNA post-surgery and monitors treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer Stage II, Colon Cancer Stage III
- What is being tested?
- Oxaliplatin, Capecitabine and Folinic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 22 Oct 2024to 1 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SAGITTARIUS trial written informed consent.
- Age ≥ 18 years.
- Histologically confirmed diagnosis of operable stage III and High-Risk stage II CC located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.
- Availability of the original FFPE tumor tissue.
- ECOG performance status 0-1.
- Normal organ functions (as defined in section 9.3).
- Women with childbearing potential (WOCBP) should complete a pregnancy test and be willing to use highly effective contraceptive methods.
Who cannot join
- History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).
- Current or recent treatment with another investigational drug or participation in another investigational study.
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- Inadequate contraception (male or female patients) if of childbearing or procreational potential.
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- Clinically relevant cardiovascular disease.
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease or any other autoimmune disease.
- Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has a medical condition that contraindicate the use of the investigational medicinal product (IMP) according to product indications.
- Prior neoadjuvant treatment administered before surgery.
Trial locations and contacts
26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 3 countries
Spain13 sites, 13 recruiting
- Recruiting
Hospital del Mar
Barcelona, Barcelona, 08003
Clara Montagut, MD, +34932483137, cmontagut@psmar.cat
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Elena Elez, MD, +349327460000, meelez@vhio.net
- Recruiting
Hospital Sant Pau Barcelona
Barcelona, 08041
David Paez, MD, +34935565631, DPaez@santpau.cat
- Recruiting
Consorci Corporació Sanitària Parc Taulí
Barcelona, 08208
Rosa Querol Niñerola, MD, +34937280609, rquerol@tauli.cat
- Recruiting
Instituto Catalán de Oncologia
Barcelona, 08908
Cristina Santos, MD, +3493267733, csantos@iconcologia.net
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
Enrique Aranda, MD, +34957736231, earandaa@seom.org
- Recruiting
Hospital Clinico Universitario San Carlos
Madrid, 28040
Javier Sastre, MD, +34913303000, jsastrev@salud.madrid.org
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, 31008
Ruth Vera, MD, +34848422576, ruth.vera.garcia@navarra.es
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Carlos López, MD, +34942 202520, carlos.lopez@scsalud.es
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15706
Juan Ruiz, MD, +34981950511, juan.ruiz.banobre@sergas.es
- Recruiting
INCLIVA Instituto de Investigación Sanitaria
Valencia, Spain, 46010
Noela Tarazona, MD, +34961973517, noetalla@incliva.es
- Recruiting
Hospital General Universitario de Valencia
Valencia, 46014
Maria José Safont, MD, +3496473400, safont_mar@gva.es
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Vicente Alonso, MD, +34976765500, valonsoo@salud.aragon.es
Italy12 sites, 12 recruiting
- Recruiting
Azienda Sanitaria Locale di Biella
Biella, Biella, 13875
Francesco Leone, MD, +3901515157503, francesco.leone@aslbi.piemonte.it
- Recruiting
Fondazione Poliambulanza
Brescia, Brescia, 25124
Michela Libertini, MD, +390303515557, michela.libertini@poliambulanza.it
- Recruiting
Istituto di Candiolo
Candiolo, Torino, 10060
Elisabetta Fenocchio, MD, +390119933250, elisabetta.fenocchio@ircc.it
- Recruiting
Azienda Ospedaliera Universitaria San Martino
Genova, Genova, 16132
Maria Stefania Sciallero, MD, +390105553302, stefania.sciallero@hsanmartino.it
- Recruiting
Istituto Europeo di Oncologia
Milan, Milano, 20141
Maria Giulia Zampino, MD, +390257489406, maria.zampino@ieo.it
- Recruiting
Ospedale Niguarda
Milan, Milan, 20162
Salvatore Siena, MD, +390264442291, salvatore.siena@ospedaleniguarda.it
- Recruiting
Ospedale Maggiore di Novara
Novara, Novara, 28100
Alessandra Gennari, MD, +3903213733822, alessandra.gennari@maggioreosp.novara.it
- Recruiting
Azienda Ospedaliera Universitaria di Parma
Parma, Parma, 43126
Francesca Negri, MD, +390521703749, fnegri@ao.pr.it
- Recruiting
Ospedale Santa Maria della Misericordia
Perugia, Perugia, 06129
Mario Mandalà, MD, +390755784205, mario.mandala@unipg.it
- Recruiting
Azienda Unità Sanitaria Locale della Romagna
Ravenna, Ravenna, 48121
Stefano Tamberi, MD, +290544287175, stefano.tamberi@auslromagna.it
- Recruiting
Policlinico Universitario Gemelli
Roma, Roma, 00168
Lisa Salvatore, MD, +390630156318, lisa.salvatore@policlinicogemelli.it
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Armando Santoro, MD, +390282244080, armando.santoro@hunimed.eu
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Sebastian Stintzing, MD, +49030450613132, sebastian.stintzing@charite.de
About this study
Official title: A Precision Medicine Trial Leveraging Blood-Based Tumor Genomics to Optimize Treatment in Operable Stage III and High-Risk Stage II Colon Cancer Patients
Background \& Rationale:
Colon cancer is a leading cause of cancer deaths, with a high recurrence rate in stage II high-risk and stage III patients due to undetectable micro-metastases. Liquid biopsy (LB) detects residual cancer DNA post-surgery and monitors treatment response.
Read more
Primary Objective:
Show that therapy based on tumor genetics and LB improves outcomes and quality of life for high-risk stage II and stage III colon cancer patients compared to conventional therapy.
Secondary Objectives:
Compare recurrence times. Evaluate side effects and quality of life. Assess cost differences. Validate LB accuracy.
Study Design: Patients are randomized into standard or personalized treatment groups based on LB results.
For positive LB results:
Randomized to standard or customized therapy. Monitor treatment response with LB.
For negative LB results:
Randomized to standard chemotherapy or follow-ups, starting treatment if a positive result appears.
Treatments:
Standard Chemotherapy:
CAPOX (capecitabine and oxaliplatin) FOLFOX (folinic acid, fluorouracil, and oxaliplatin)
Personalized Treatments:
Customized chemotherapy with CAPOX. Immunotherapy with nivolumab and ipilimumab. Targeted therapy with trastuzumab and pertuzumab. FOLFOX with anti-EGFR (epidermal growth factor receptor) therapy (panitumumab).
Population: 700 patients with operable stage III and high-risk stage II colon cancer.
Inclusion Criteria:
Aged 18 or older. Confirmed diagnosis. Tumor tissue sample available.
Exclusion Criteria:
History of other tumors within five years. Metastatic disease or recent experimental study participation. Major cardiovascular diseases, intestinal obstruction, autoimmune diseases, neuropathy, HIV (Human Immunodeficiency Virus), active TB (Tuberculosis), or hepatitis B/C infection.
Medical conditions contraindicating treatment. Prior neoadjuvant treatment administered before surgery.
Endpoints:
Primary:
Evaluate disease recurrence after two years.
Secondary:
Assess disease recurrence and overall survival at 3 and 5 years. Measure treatment safety and tolerability. Validate LB accuracy. Monitor quality of life using questionnaires.
The study will last 5 years and be conducted in 25-30 hospitals across Italy, Spain, and Germany.
Read the detailed description
Background \& Rationale:
Colon cancer (CC) is the second most lethal malignancy, accounting for nearly 10% of all cancer-related deaths. Despite over two-thirds of CC patients undergoing surgical resection, 50% of stage III patients relapse within 5 years. Adjuvant chemotherapy (ACT), typically involving oxaliplatin combined with a fluoropyrimidine, offers only a 10-15% survival advantage over 5-fluorouracil alone. The benefit from ACT is predicted by clinical and pathological parameters rather than metastatic propensity or biological sensitivity, and its success is limited by high toxicity levels, particularly oxaliplatin-induced peripheral sensory neuropathy.
Liquid biopsy (LB) profiling circulating tumor DNA (ctDNA) has emerged as an effective diagnostic tool for early cancer detection, staging, prognosis, monitoring drug resistance, and detecting minimal residual disease (MRD). Retrospective studies show that ctDNA detection post-surgery and post-ACT is associated with high recurrence risk and worse recurrence-free survival (RFS) in stage I-III colorectal cancer (CRC) patients. Prospective studies confirm ctDNA's prognostic value post-surgery and ACT.
SAGITTARIUS Trial Objectives:
Diagnosing MRD After Surgery: Utilize post-surgical LB to identify high-risk tumors and stratify stage II high-risk and stage III CC patients, enabling targeted treatments and reducing unnecessary chemotoxicity.
Establishing the Efficacy of Adjuvant Chemotherapy and Targeted Therapies: Tailor treatment based on the individual tumor genomic landscape to improve clinical outcomes and quality of life compared to conventional chemotherapy.
Study Design:
The SAGITTARIUS trial is a randomized phase III study designed to demonstrate the efficacy of ctDNA detection in guiding adjuvant clinical management of stage III and high-risk stage II CC patients. The trial employs the CE-IVD marked tumor-informed MRD assay Signatera (NATERA® Inc.) and comprehensive tumor genomic profiling (TruSight Oncology Comprehensive (EU), TSOComp, Illumina, Inc.). These tools will provide a detailed molecular genomic landscape of each patient's tumor, with results available within 8 weeks post-surgery for timely adjuvant treatment initiation.
Patient Stratification and Randomization:
Patients are stratified based on ctDNA status into two main trials:
Trial-1 (ctDNA Positive Patients): Includes further stratification based on MSS/MMRp extended RAS/RAF mutation status and MSI-H/MMRd status. Treatment arms include standard chemotherapy (CAPOX/FOLFOX) or personalized treatments with reassessment of ctDNA status guiding subsequent therapies.
Trial-2 (ctDNA Negative Patients): Patients are randomized to either a physician-choice chemotherapy regimen or intensive follow-up, with interventional LBs at specified intervals.
Therapeutic Approaches:
Standard Chemotherapy Regimens: CAPOX (capecitabine and oxaliplatin) and FOLFOX (folinic acid, fluorouracil, and oxaliplatin).
Personalized Therapies: Include options such as FOLFIRI or TEMIRI for RAS/RAF-mutated tumors, double immunotherapy (nivolumab and ipilimumab) for MSI-H/MMRd, anti-HER2 therapy (trastuzumab and pertuzumab) for HER2-amplified tumors, and FOLFOX combined with anti-EGFR (panitumumab) for multiple wild-type tumors.
Data Collection and Analysis:
Data will be collected through regular clinical evaluations, imaging studies, and questionnaires to assess various endpoints, including RFS, overall survival, treatment safety, tolerability, and quality of life. The primary endpoint is the 2-year RFS in ctDNA positive patients, while secondary endpoints include 3 and 5-year RFS, overall survival, and the accuracy of LB in detecting residual disease. Statistical analyses will follow the intention-to-treat principle, utilizing the Kaplan-Meier method for time-to-event data and stratified log-rank tests for comparison.
- Conditions
- Colon Cancer Stage II, Colon Cancer Stage III
- Being tested
- Oxaliplatin, Capecitabine, Folinic acid, Fluorouracil, Temozolomide
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Oxaliplatin is used as part of the chemotherapy regimens for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following ways:
CAPOX Regimen: Oxaliplatin 130 mg/m² is given intravenously on day 1, in combination with capecitabine 1000 mg/m² taken orally twice daily on days 1-14 of each 21-day cycle.
FOLFOX Regimen: Oxaliplatin 85 mg/m² is administered intravenously on day 1, alongside folinic acid 400 mg/m² and fluorouracil 400 mg/m² IV bolus, followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle.
Dosages are standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results, typically up to 6 months.
CapecitabineDrug
Capecitabine is used as part of the chemotherapy regimens for patients with ctDNA+ and ctDNA- results in the SAGITTARIUS trial. It is administered in the following ways:
CAPOX Regimen: Capecitabine 1000 mg/m² is taken orally twice daily on days 1-14 of each 21-day cycle, in combination with oxaliplatin 130 mg/m² given intravenously on day 1.
Capecitabine Monotherapy for High-Risk ctDNA- Patients: Capecitabine 1250 mg/m² is taken orally twice daily on days 1-14 of each 21-day cycle for patients identified as high-risk but with negative ctDNA results.
The dosage of capecitabine is standardized, while the duration of treatment varies based on patient response and monitoring results, typically up to 6 months.
Folinic acidDrug
Folinic acid is used as part of the FOLFOX chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following way:
FOLFOX Regimen: Folinic acid (leucovorin) 400 mg/m² is given intravenously on day 1, in combination with oxaliplatin 85 mg/m² IV on day 1 and fluorouracil 400 mg/m² IV bolus followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle.
The dosage of folinic acid is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results, typically up to 6 months.
FluorouracilDrug
Fluorouracil is used as part of the FOLFOX chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following way:
FOLFOX Regimen: Fluorouracil 400 mg/m² is given as an intravenous (IV) bolus on day 1, followed by 2400 mg/m² as a continuous IV infusion over 46 hours, in combination with folinic acid (leucovorin) 400 mg/m² IV on day 1 and oxaliplatin 85 mg/m² IV on day 1. This regimen is repeated every 14 days.
The dosage of fluorouracil is standardized, while the duration of treatment is typically up to 6 months, adjusted based on patient response and liquid biopsy results.
TemozolomideDrug
Temozolomide is used as part of the tailored chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial, specifically for those with MGMT-negative tumors. It is administered in the following way:
TEMIRI Regimen: Temozolomide 150-200 mg/m² is taken orally once daily on days 1-5 of each 28-day cycle, in combination with irinotecan 250 mg/m² administered intravenously on day 1 of each cycle.
The dosage of temozolomide is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.
IrinotecanDrug
Irinotecan is used as part of the tailored chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following ways:
TEMIRI Regimen: Irinotecan 250 mg/m² is administered intravenously on day 1 of each 28-day cycle, in combination with temozolomide 150-200 mg/m² taken orally once daily on days 1-5.
FOLFIRI Regimen: Irinotecan 180 mg/m² is given intravenously on day 1, in combination with folinic acid (leucovorin) 400 mg/m² IV, fluorouracil 400 mg/m² IV bolus, followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle.
The dosage of irinotecan is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.
NivolumabDrug
Nivolumab is used as part of the tailored immunotherapy regimen for patients with ctDNA+ results, specifically for those with MSI-H/MMRd tumors in the SAGITTARIUS trial. It is administered in the following way:
Nivolumab: 3 mg/kg is given intravenously every 2 weeks. This dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.
IpilimumabDrug
Ipilimumab is used as part of the tailored immunotherapy regimen for patients with ctDNA+ results, specifically for those with MSI-H/MMRd tumors in the SAGITTARIUS trial. It is administered in the following way:
Ipilimumab: 1 mg/kg is given intravenously every 6 weeks. This dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.
TrastuzumabDrug
Trastuzumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with HER2-amplified tumors in the SAGITTARIUS trial. It is administered in the following way:
Trastuzumab: 8 mg/kg as an initial intravenous (IV) loading dose, followed by 6 mg/kg IV every 3 weeks.
The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.
PertuzumabDrug
Pertuzumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with HER2-amplified tumors in the SAGITTARIUS trial. It is administered in the following way:
Pertuzumab: 840 mg as an initial intravenous (IV) loading dose, followed by 420 mg IV every 3 weeks.
The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.
PanitumumabDrug
Panitumumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with multiple wild-type tumors (MSS/MMRp extended RAS/RAF wild-type) in the SAGITTARIUS trial. It is administered in the following way:
Panitumumab: 6 mg/kg is given intravenously every 2 weeks. The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.
| Study group | Role | What they receive |
|---|---|---|
| Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Standard Therapy | Active comparator | CAPOX/FOLFOX for 6 months or until toxicity Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Folinic acid; Drug: Fluorouracil |
| Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Tailored Therapy | Experimental | CAPOX for 3 months with an interventional liquid biopsy at the end of the treatment. Patients still resulting ctDNA+ will be switched to a tailored therapy (FOLFIRI for RAS/RAF-mutated and MGMT-positive tumors or TEMIRI for RAS/RAF-mutated and MGMT-negative tumors) for 6 months or until toxicity. On the other hand, ctDNA- patients will continue CAPOX up to 3 months, and their ctDNA status will be re-assessed at the end of the treatment. Patients remaining ctDNA- will enter into follow-up, while patients resulting ctDNA+ will be switched to the tailored therapy. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Folinic acid; Drug: Fluorouracil; Drug: Temozolomide; Drug: Irinotecan |
| Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Standard Therapy | Active comparator | CAPOX/FOLFOX for 6 months or until toxicity Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Folinic acid; Drug: Fluorouracil |
| Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Tailored Therapy | Experimental | Tailored therapy (nivolumab+ipilimumab for MSI-H/MMRd: MSI-H/MMRd tumors and MSS/MMRp tumors with POLE mutations and a high TMB or trastuzumab + pertuzumab for MSS/MMRp HER2-amplified tumors or panitumumab+folfox for MSS/MMRp RAS/RAF/HER2 wild-type) for 3 months, at the end, the ctDNA status of patients will be reassessed to further guide their subsequent treatments. Patients still ctDNA+ at will be switched to standard therapy. On the other hand, patients undergoing seroconversion will continue the same therapy for 3 further months and will be then re-assessed at the end of the treatment. Patients resulting ctDNA- will enter into Follow-up, while patients resulting ctDNA+ will be switched to the standard therapy. Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Panitumumab |
| Trial-2 (ctDNA-) Standard Therapy | Active comparator | Chemotherapy regimen at prior declared physician choice (CAPE/CAPOX/FOLFOX/5-FU±LV). Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Folinic acid; Drug: Fluorouracil |
| Trial-2 (ctDNA-) Intensive Follow-up | No intervention | Intensive follow-up for 6 months (except for MSS Stage III High-risk patients which will be treated with CAPE). |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Recurrence-Free Survival (RFS)
The primary outcome measure is the 2-year recurrence-free survival (RFS) rate, defined as the proportion of patients who remain free of disease recurrence two years after surgery. This metric is assessed using regular clinical evaluations and imaging studies. Recurrence is determined by the reappearance of colon cancer as confirmed by histological, radiological, or clinical findings.
Measured: Assessed at 2 years post-surgery
Secondary outcomes (6)
3-Year Recurrence-Free Survival (RFS)
The secondary outcome measure is the 3-year recurrence-free survival (RFS) rate, defined as the proportion of patients who remain free of disease recurrence three years after surgery. This metric is assessed using regular clinical evaluations and imaging studies. Recurrence is determined by the reappearance of colon cancer as confirmed by histological, radiological, or clinical findings.
Measured: Assessed at 3 years post-surgery
5-Year Overall Survival (OS)
The secondary outcome measure is the 5-year overall survival (OS) rate, defined as the proportion of patients who are alive five years after surgery, regardless of disease status. This metric is assessed using regular clinical evaluations and follow-ups.
Measured: Assessed at 5 years post-surgery
Treatment Safety and Tolerability
This secondary outcome measure evaluates the safety and tolerability of the treatments, including both standard and personalized therapies. It involves recording and analyzing the incidence, severity, and type of adverse events experienced by patients during the treatment period, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Assessed throughout the treatment period, up to 6 months
Sensitivity and Specificity of Liquid Biopsy in Detecting Residual Disease
This outcome measure evaluates the effectiveness of liquid biopsy in detecting residual disease by comparing its results with traditional imaging techniques (CT scans, MRIs) and clinical findings. Sensitivity will be measured by the ability of liquid biopsy to correctly identify patients with residual disease, expressed as a percentage of positive results confirmed by imaging and clinical findings. Specificity will be measured by the ability to correctly identify patients without residual disease, also expressed as a percentage of negative results confirmed. The study will also assess the correlation between liquid biopsy results and traditional methods to ensure consistency in detecting residual disease.
Measured: Assessed at regular intervals post-surgery, up to 2 years
Assessment of Quality of Life Using FACT-C Questionnaire
This secondary outcome measure evaluates the impact of treatment on patients' quality of life specific to colorectal cancer using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire. The FACT-C assesses quality of life across physical, social/family, emotional, and functional well-being domains. The questionnaire provides a score based on patient responses to various questions, with each question rated on a scale from 0 to 4, with higher scores indicating better quality of life.
Measured: Assessed at regular intervals during the treatment period and during follow-up, up to 3 years or up to the date of first documented progression or the date of consent withdrawal
Assessment of Quality of Life Using EQ-5D-5L Questionnaire
This secondary outcome measure evaluates the impact of treatment on patients' quality of life across five dimensions using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L evaluates quality of life in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a scale from 1 to 5, with 1 indicating no problems and 5 indicating extreme problems. The index score ranges from 0 to 1, with higher scores indicating better quality of life. Additionally, the EQ-5D-5L includes a visual analog scale (VAS) ranging from 0 (worst health imaginable) to 100 (best health imaginable) to assess the patient's overall health.
Measured: Assessed at regular intervals during the treatment period and during follow-up, up to 3 years or up to the date of first documented progression or the date of consent withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start22 Oct 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clara Montagut, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490536
- Sponsor's protocol ID
- IFOM-CPT009/2022/PO008
- Other IDs
- 2023-509851-15-00, 2023
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Precision Medicine Trial Leveraging Blood-Based Tumor Genomics to Optimize Treatment in Operable Stage III and High-Risk Stage II Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT06490536
- Acronym / sponsor ID
- IFOM-CPT009/2022/PO008
- Conditions
- Colon Cancer Stage II, Colon Cancer Stage III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular OncologyUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background \& Rationale:
Colon cancer is a leading cause of cancer deaths, with a high recurrence rate in stage II high-risk and stage III patients due to undetectable micro-metastases. Liquid biopsy (LB) detects residual cancer DNA post-surgery and monitors treatment response.
Primary Objective:
Show that therapy based on tumor genetics and LB improves outcomes and quality of life for high-risk stage II and stage III colon cancer patients compared to conventional therapy.
Secondary Objectives:
Compare recurrence times. Evaluate side effects and quality of life. Assess cost differences. Validate LB accuracy.
Study Design: Patients are randomized into standard or personalized treatment groups based on LB results.
For positive LB results:
Randomized to standard or customized therapy. Monitor treatment response with LB.
For negative LB results:
Randomized to standard chemotherapy or follow-ups, starting treatment if a positive result appears.
Treatments:
Standard Chemotherapy:
CAPOX (capecitabine and oxaliplatin) FOLFOX (folinic acid, fluorouracil, and oxaliplatin)
Personalized Treatments:
Customized chemotherapy with CAPOX. Immunotherapy with nivolumab and ipilimumab. Targeted therapy with trastuzumab and pertuzumab. FOLFOX with anti-EGFR (epidermal growth factor receptor) therapy (panitumumab).
Population: 700 patients with operable stage III and high-risk stage II colon cancer.
Inclusion Criteria:
Aged 18 or older. Confirmed diagnosis. Tumor tissue sample available.
Exclusion Criteria:
History of other tumors within five years. Metastatic disease or recent experimental study participation. Major cardiovascular diseases, intestinal obstruction, autoimmune diseases, neuropathy, HIV (Human Immunodeficiency Virus), active TB (Tuberculosis), or hepatitis B/C infection.
Medical conditions contraindicating treatment. Prior neoadjuvant treatment administered before surgery.
Endpoints:
Primary:
Evaluate disease recurrence after two years.
Secondary:
Assess disease recurrence and overall survival at 3 and 5 years. Measure treatment safety and tolerability. Validate LB accuracy. Monitor quality of life using questionnaires.
The study will last 5 years and be conducted in 25-30 hospitals across Italy, Spain, and Germany.
Detailed description
Background \& Rationale:
Colon cancer (CC) is the second most lethal malignancy, accounting for nearly 10% of all cancer-related deaths. Despite over two-thirds of CC patients undergoing surgical resection, 50% of stage III patients relapse within 5 years. Adjuvant chemotherapy (ACT), typically involving oxaliplatin combined with a fluoropyrimidine, offers only a 10-15% survival advantage over 5-fluorouracil alone. The benefit from ACT is predicted by clinical and pathological parameters rather than metastatic propensity or biological sensitivity, and its success is limited by high toxicity levels, particularly oxaliplatin-induced peripheral sensory neuropathy.
Liquid biopsy (LB) profiling circulating tumor DNA (ctDNA) has emerged as an effective diagnostic tool for early cancer detection, staging, prognosis, monitoring drug resistance, and detecting minimal residual disease (MRD). Retrospective studies show that ctDNA detection post-surgery and post-ACT is associated with high recurrence risk and worse recurrence-free survival (RFS) in stage I-III colorectal cancer (CRC) patients. Prospective studies confirm ctDNA's prognostic value post-surgery and ACT.
SAGITTARIUS Trial Objectives:
Diagnosing MRD After Surgery: Utilize post-surgical LB to identify high-risk tumors and stratify stage II high-risk and stage III CC patients, enabling targeted treatments and reducing unnecessary chemotoxicity.
Establishing the Efficacy of Adjuvant Chemotherapy and Targeted Therapies: Tailor treatment based on the individual tumor genomic landscape to improve clinical outcomes and quality of life compared to conventional chemotherapy.
Study Design:
The SAGITTARIUS trial is a randomized phase III study designed to demonstrate the efficacy of ctDNA detection in guiding adjuvant clinical management of stage III and high-risk stage II CC patients. The trial employs the CE-IVD marked tumor-informed MRD assay Signatera (NATERA® Inc.) and comprehensive tumor genomic profiling (TruSight Oncology Comprehensive (EU), TSOComp, Illumina, Inc.). These tools will provide a detailed molecular genomic landscape of each patient's tumor, with results available within 8 weeks post-surgery for timely adjuvant treatment initiation.
Patient Stratification and Randomization:
Patients are stratified based on ctDNA status into two main trials:
Trial-1 (ctDNA Positive Patients): Includes further stratification based on MSS/MMRp extended RAS/RAF mutation status and MSI-H/MMRd status. Treatment arms include standard chemotherapy (CAPOX/FOLFOX) or personalized treatments with reassessment of ctDNA status guiding subsequent therapies.
Trial-2 (ctDNA Negative Patients): Patients are randomized to either a physician-choice chemotherapy regimen or intensive follow-up, with interventional LBs at specified intervals.
Therapeutic Approaches:
Standard Chemotherapy Regimens: CAPOX (capecitabine and oxaliplatin) and FOLFOX (folinic acid, fluorouracil, and oxaliplatin).
Personalized Therapies: Include options such as FOLFIRI or TEMIRI for RAS/RAF-mutated tumors, double immunotherapy (nivolumab and ipilimumab) for MSI-H/MMRd, anti-HER2 therapy (trastuzumab and pertuzumab) for HER2-amplified tumors, and FOLFOX combined with anti-EGFR (panitumumab) for multiple wild-type tumors.
Data Collection and Analysis:
Data will be collected through regular clinical evaluations, imaging studies, and questionnaires to assess various endpoints, including RFS, overall survival, treatment safety, tolerability, and quality of life. The primary endpoint is the 2-year RFS in ctDNA positive patients, while secondary endpoints include 3 and 5-year RFS, overall survival, and the accuracy of LB in detecting residual disease. Statistical analyses will follow the intention-to-treat principle, utilizing the Kaplan-Meier method for time-to-event data and stratified log-rank tests for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Standard Therapy | Active comparator | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Folinic acid, Drug: FluorouracilCAPOX/FOLFOX for 6 months or until toxicity |
| Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Tailored Therapy | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Folinic acid, Drug: Fluorouracil, Drug: Temozolomide, Drug: IrinotecanCAPOX for 3 months with an interventional liquid biopsy at the end of the treatment. Patients still resulting ctDNA+ will be switched to a tailored therapy (FOLFIRI for RAS/RAF-mutated and MGMT-positive tumors or TEMIRI for RAS/RAF-mutated and MGMT-negative tumors) for 6 months or until toxicity. On the other hand, ctDNA- patients will continue CAPOX up to 3 months, and their ctDNA status will be re-assessed at the end of the treatment. Patients remaining ctDNA- will enter into follow-up, while patients resulting ctDNA+ will be switched to the tailored therapy. |
| Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Standard Therapy | Active comparator | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Folinic acid, Drug: FluorouracilCAPOX/FOLFOX for 6 months or until toxicity |
| Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Tailored Therapy | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: Trastuzumab, Drug: Pertuzumab, Drug: PanitumumabTailored therapy (nivolumab+ipilimumab for MSI-H/MMRd: MSI-H/MMRd tumors and MSS/MMRp tumors with POLE mutations and a high TMB or trastuzumab + pertuzumab for MSS/MMRp HER2-amplified tumors or panitumumab+folfox for MSS/MMRp RAS/RAF/HER2 wild-type) for 3 months, at the end, the ctDNA status of patients will be reassessed to further guide their subsequent treatments. Patients still ctDNA+ at will be switched to standard therapy. On the other hand, patients undergoing seroconversion will continue the same therapy for 3 further months and will be then re-assessed at the end of the treatment. Patients resulting ctDNA- will enter into Follow-up, while patients resulting ctDNA+ will be switched to the standard therapy. |
| Trial-2 (ctDNA-) Standard Therapy | Active comparator | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Folinic acid, Drug: FluorouracilChemotherapy regimen at prior declared physician choice (CAPE/CAPOX/FOLFOX/5-FU±LV). |
| Trial-2 (ctDNA-) Intensive Follow-up | No intervention | –Intensive follow-up for 6 months (except for MSS Stage III High-risk patients which will be treated with CAPE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- SAGITTARIUS trial written informed consent.
- Age ≥ 18 years.
- Histologically confirmed diagnosis of operable stage III and High-Risk stage II CC located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.
- Availability of the original FFPE tumor tissue.
- ECOG performance status 0-1.
Key exclusion criteria (14 listed)
- History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).
- Current or recent treatment with another investigational drug or participation in another investigational study.
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinOxaliplatin is used as part of the chemotherapy regimens for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following ways: CAPOX Regimen: Oxaliplatin 130 mg/m² is given intravenously on day 1, in combination with capecitabine 1000 mg/m² taken orally twice daily on days 1-14 of each 21-day cycle. FOLFOX Regimen: Oxaliplatin 85 mg/m² is administered intravenously on day 1, alongside folinic acid 400 mg/m² and fluorouracil 400 mg/m² IV bolus, followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle. Dosages are standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results, typically up to 6 months. | Drug | Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Standard Therapy, Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Tailored Therapy, Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Standard Therapy, Trial-2 (ctDNA-) Standard Therapy |
| CapecitabineCapecitabine is used as part of the chemotherapy regimens for patients with ctDNA+ and ctDNA- results in the SAGITTARIUS trial. It is administered in the following ways: CAPOX Regimen: Capecitabine 1000 mg/m² is taken orally twice daily on days 1-14 of each 21-day cycle, in combination with oxaliplatin 130 mg/m² given intravenously on day 1. Capecitabine Monotherapy for High-Risk ctDNA- Patients: Capecitabine 1250 mg/m² is taken orally twice daily on days 1-14 of each 21-day cycle for patients identified as high-risk but with negative ctDNA results. The dosage of capecitabine is standardized, while the duration of treatment varies based on patient response and monitoring results, typically up to 6 months. | Drug | Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Standard Therapy, Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Tailored Therapy, Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Standard Therapy, Trial-2 (ctDNA-) Standard Therapy |
| Folinic acidFolinic acid is used as part of the FOLFOX chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following way: FOLFOX Regimen: Folinic acid (leucovorin) 400 mg/m² is given intravenously on day 1, in combination with oxaliplatin 85 mg/m² IV on day 1 and fluorouracil 400 mg/m² IV bolus followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle. The dosage of folinic acid is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results, typically up to 6 months. | Drug | Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Standard Therapy, Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Tailored Therapy, Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Standard Therapy, Trial-2 (ctDNA-) Standard Therapy |
| FluorouracilFluorouracil is used as part of the FOLFOX chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following way: FOLFOX Regimen: Fluorouracil 400 mg/m² is given as an intravenous (IV) bolus on day 1, followed by 2400 mg/m² as a continuous IV infusion over 46 hours, in combination with folinic acid (leucovorin) 400 mg/m² IV on day 1 and oxaliplatin 85 mg/m² IV on day 1. This regimen is repeated every 14 days. The dosage of fluorouracil is standardized, while the duration of treatment is typically up to 6 months, adjusted based on patient response and liquid biopsy results. | Drug | Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Standard Therapy, Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Tailored Therapy, Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Standard Therapy, Trial-2 (ctDNA-) Standard Therapy |
| TemozolomideTemozolomide is used as part of the tailored chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial, specifically for those with MGMT-negative tumors. It is administered in the following way: TEMIRI Regimen: Temozolomide 150-200 mg/m² is taken orally once daily on days 1-5 of each 28-day cycle, in combination with irinotecan 250 mg/m² administered intravenously on day 1 of each cycle. The dosage of temozolomide is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results. | Drug | Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Tailored Therapy |
| IrinotecanIrinotecan is used as part of the tailored chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following ways: TEMIRI Regimen: Irinotecan 250 mg/m² is administered intravenously on day 1 of each 28-day cycle, in combination with temozolomide 150-200 mg/m² taken orally once daily on days 1-5. FOLFIRI Regimen: Irinotecan 180 mg/m² is given intravenously on day 1, in combination with folinic acid (leucovorin) 400 mg/m² IV, fluorouracil 400 mg/m² IV bolus, followed by 2400 mg/m² IV infusion over 46 hours, in each 14-day cycle. The dosage of irinotecan is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results. | Drug | Trial-1 (ctDNA+) Strata-1 (MSS/MMRp extendend RAS/RAFmut) Tailored Therapy |
| NivolumabNivolumab is used as part of the tailored immunotherapy regimen for patients with ctDNA+ results, specifically for those with MSI-H/MMRd tumors in the SAGITTARIUS trial. It is administered in the following way: Nivolumab: 3 mg/kg is given intravenously every 2 weeks. This dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results. | Drug | Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Tailored Therapy |
| IpilimumabIpilimumab is used as part of the tailored immunotherapy regimen for patients with ctDNA+ results, specifically for those with MSI-H/MMRd tumors in the SAGITTARIUS trial. It is administered in the following way: Ipilimumab: 1 mg/kg is given intravenously every 6 weeks. This dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results. | Drug | Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Tailored Therapy |
| TrastuzumabTrastuzumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with HER2-amplified tumors in the SAGITTARIUS trial. It is administered in the following way: Trastuzumab: 8 mg/kg as an initial intravenous (IV) loading dose, followed by 6 mg/kg IV every 3 weeks. The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results. | Drug | Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Tailored Therapy |
| PertuzumabPertuzumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with HER2-amplified tumors in the SAGITTARIUS trial. It is administered in the following way: Pertuzumab: 840 mg as an initial intravenous (IV) loading dose, followed by 420 mg IV every 3 weeks. The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results. | Drug | Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Tailored Therapy |
| PanitumumabPanitumumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with multiple wild-type tumors (MSS/MMRp extended RAS/RAF wild-type) in the SAGITTARIUS trial. It is administered in the following way: Panitumumab: 6 mg/kg is given intravenously every 2 weeks. The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results. | Drug | Trial-1 (ctDNA+) Strata-2 (MSI-H/MMRd & MSS/MMRp extended RAS/RAFwt) Tailored Therapy |
Primary outcome
2-Year Recurrence-Free Survival (RFS)
Time frame: Assessed at 2 years post-surgery
The primary outcome measure is the 2-year recurrence-free survival (RFS) rate, defined as the proportion of patients who remain free of disease recurrence two years after surgery. This metric is assessed using regular clinical evaluations and imaging studies. Recurrence is determined by the reappearance of colon cancer as confirmed by histological, radiological, or clinical findings.
6 secondary outcomes
3-Year Recurrence-Free Survival (RFS)
Time frame: Assessed at 3 years post-surgery
5-Year Overall Survival (OS)
Time frame: Assessed at 5 years post-surgery
Treatment Safety and Tolerability
Time frame: Assessed throughout the treatment period, up to 6 months
Sensitivity and Specificity of Liquid Biopsy in Detecting Residual Disease
Time frame: Assessed at regular intervals post-surgery, up to 2 years
Assessment of Quality of Life Using FACT-C Questionnaire
Time frame: Assessed at regular intervals during the treatment period and during follow-up, up to 3 years or up to the date of first documented progression or the date of consent withdrawal
Assessment of Quality of Life Using EQ-5D-5L Questionnaire
Time frame: Assessed at regular intervals during the treatment period and during follow-up, up to 3 years or up to the date of first documented progression or the date of consent withdrawal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clara Montagut principal investigator
Hospital del Mar
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxaliplatin, Capecitabine and Folinic acid in people with Colon Cancer Stage II and Colon Cancer Stage III, run by IFOM ETS - The AIRC Institute of Molecular Oncology at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Spain, Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Marsoni (+39 02.574303862, sagittarius@ifom.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Recurrence-Free Survival (RFS) (time frame: Assessed at 2 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.