Metastatic Colorectal AdenocarcinomaPhase 2NCT05312398
CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen
A Phase 2 study testing Cetuximab, FOLFIRI and FOLFOX regimen in people with Metastatic Colorectal Adenocarcinoma, run by University of Campania Luigi Vanvitelli at 25 sites in Italy.
Trial summary
This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX, irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Adenocarcinoma
- What is being tested?
- Cetuximab, FOLFIRI and FOLFOX regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 25 sitesItaly
- Study dates
- 15 Jul 2021to 15 Aug 2026
- Phase
- Phase 2
- 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
- Histologically proven diagnosis of colorectal adenocarcinoma
- Diagnosis of metastatic disease
- RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis
- Measurable disease according to Response Evaluation Criteria in Solid Tumors RECIST criteria, vers.1.1)
- Male or female patients ≥ 18 years of age
- ECOG Performance Status 0,1
Show all 18Show fewer
- Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters:
- Bone marrow:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 100 x 109/L
- Liver function:
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN
- Renal function:
- Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
- If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment
- If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 3 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate
- Signed informed consent obtained before screening.
Who cannot join
- Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic acid,bevacizumab, trifluridine-tipiracil, regorafenib
- Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease
- Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix
- Pregnancy (exclusion to be ascertained by a beta hCG test)
- Breastfeeding
- Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception•
Show all 20Show fewer
- Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification)
- Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
- Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
- Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
- Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
- Known or clinically suspected brain metastases
- History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
- Severe, non-healing wounds, ulcers or bone fractures
- Uncontrolled hypertension
- Marked proteinuria (nephrotic syndrome)
- Known DPD deficiency (specific screening not required)
- Known history of alcohol or drug abuse
- A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
- Absent or restricted legal capacity
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Italy25 sites
Ente Ecclesiastico Ospedale Generale Regionale 'F. Miulli'
Acquaviva delle Fonti, BA
A.O.U. Ospedali Riuniti
Ancona, AN
IRCCS Istituto Tumori 'Giovanni Paolo II'
Bari, BA
Ospedale Sacro Cuore di Gesù - FATEBENEFRATELLI
Benevento, BN
P.O. Antonio Perrino
Brindisi, BR
Ospedale IRCCS 'Saverio de Bellis'
Castellana Grotte, BA
A.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima
Catania, CT
A.O.U. Mater Domini
Catanzaro, CZ
P.O. 'Vito Fazzi'
Lecce, LE
Istituto Europeo di Oncologia
Milan, MI
A.O.U. Cagliari - Presidio Policlinico D. Casula
Monserrato, CA
A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"
Naples
Istituto Nazionale Tumori 'Fondazione G. Pascale'
Naples
Istituto Oncologico Veneto IRCCS
Padova, PD
A.O.U. Policlinico 'P. Giaccone'
Palermo, PA
A.O.U. Pisana
Pisa, PI
A.O. San Carlo
Potenza, PZ
A.S.P. Ragusa - Ospedale Maria Paternò Arezzo
Ragusa, RG
A.U.S.L. - IRCCS di Reggio Emilia - P.O. Arcispedale S.Maria Nuova
Reggio Emilia, RE
A.O. San Camillo-Forlanini
Roma, RM
Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS
Roma, RM
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG
Ospedale San Giuseppe Moscati
Statte, TA
A.O. Ordine Mauriziano
Torino, TO
A.O. 'Pia Fondazione Cardinale G. Panico'
Tricase, LE
About this study
Official title: CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio- Marker-driven Cetuximab-based Treatment Regimen Over 3 Treatment Lines in mCRC Patients With RAS/BRAF wt Tumors at Start of First Line
This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX, irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status.
Read the detailed description
Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be prospectively performed before each line of treatment, mCRC patients will be treated with cetuximab in combination with chemotherapy throughout three lines of therapy, as follows: FOLFIRI plus cetuximab (first line); FOLFOX plus cetuximab (second line); irinotecan plus cetuximab (third line) in case of RAS/BRAF WT at each time point of progression. If at progression after the first line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with FOLFOX plus bevacizumab as the second line of therapy. If at progression after the second line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with regorafenib or trifluridine-tipiracil (investigator's choice), as third line of therapy. Each treatment will be administered using standard doses and schedules until progression of disease or unacceptable toxicity.
This study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with FOLFOX plus bevacizumab, having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Being tested
- Cetuximab, FOLFIRI, FOLFOX regimen, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
I LINE:
- FOLFIRI + cetuximab
FOLFIRI: 200 mg L-folinic acid with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.
Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter
II LINE:
- FOLFOX + cetuximab
FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.
Cetuximab: as I line
THIRD LINE:
- Irinotecan + cetuximab
Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line
FOLFIRIDrug
I LINE:
- FOLFIRI + cetuximab
FOLFIRI: 200 mg L-folinic acid given concurrently with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.
Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter
FOLFOX regimenDrug
Also called FOLFOX
II LINE:
- FOLFOX + cetuximab
FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.
Cetuximab: as I line
IrinotecanDrug
III LINE:
- Irinotecan + cetuximab
Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | This is an open-label phase II study investigating the efficacy and safety of a bio-marker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line. Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be prospectively performed before each line of treatment, mCRC patients will be treated with cetuximab in combination with chemotherapy throughout three lines of therapy, as follows:
* FOLFIRI plus cetuximab (first line);
* FOLFOX plus cetuximab (second line);
* irinotecan plus cetuximab (third line).
If at progression after the first line or after the second line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with FOLFOX plus bevacizumab as second line of therapy, or with regorafenib or with trifluridine-tipiracil (investigator's choice) as third line therapy. Receives: Drug: Cetuximab; Drug: FOLFIRI; Drug: FOLFOX regimen; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
RR
Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRCregimen over 3 treatment lines in patients with RAS/BRAF wild type (WT) mCRC at start of first line therapy
Measured: up to 59 months
Secondary outcomes (5)
PFS
Progression free survival (PFS) for each line
Measured: from 8 weeks to 59 months (from the start of therapy until the first observation of disease progression or death due to any cause)
OS
Overall Survival
Measured: up to 59 months
AE
Safety: Adverse events graded according NCI CTCAE v 5.0
Measured: from screening up to 59 months
EORTC Core Quality of Life questionnaire EORTC QLQ C30
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items
Measured: At screening, for each line of therapy at Week 4, at Week 25 of treatment start and at progression
DERMATOLOGY LIFE QUALITY INDEX (DLQI)
The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week.
Measured: at screening, for each line of therapy at Week 4, at Week 25 of treatment start and at progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 Jul 2021
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal AdenocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fortunato Ciardiello, University of Campania Luigi Vanvitelli
- Investigators
- Fortunato Ciardiello, Principal investigator, A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312398
- Sponsor's protocol ID
- CAPRI2-MS062202-0123
- Status last verified
- May 2025
- First submitted
- 1 Mar 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martini G, Ciardiello D, Napolitano S, Martinelli E, Troiani T, Latiano TP, Avallone A, Normanno N, Di Maio M, Maiello E, Ciardiello F. Efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wild type tumors at start of first line: The CAPRI 2 GOIM trial. Front Oncol. 2023 Feb 13;13:1069370. doi: 10.3389/fonc.2023.1069370. eCollection 2023.
PubMed 36860319
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio- Marker-driven Cetuximab-based Treatment Regimen Over 3 Treatment Lines in mCRC Patients With RAS/BRAF wt Tumors at Start of First Line
- ClinicalTrials.gov ID
- NCT05312398
- Acronym / sponsor ID
- CAPRI2-MS062202-0123
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 5 Apr 2022 (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.
This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX, irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status.
Detailed description
Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be prospectively performed before each line of treatment, mCRC patients will be treated with cetuximab in combination with chemotherapy throughout three lines of therapy, as follows: FOLFIRI plus cetuximab (first line); FOLFOX plus cetuximab (second line); irinotecan plus cetuximab (third line) in case of RAS/BRAF WT at each time point of progression. If at progression after the first line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with FOLFOX plus bevacizumab as the second line of therapy. If at progression after the second line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with regorafenib or trifluridine-tipiracil (investigator's choice), as third line of therapy. Each treatment will be administered using standard doses and schedules until progression of disease or unacceptable toxicity.
This study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with FOLFOX plus bevacizumab, having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Cetuximab, Drug: FOLFIRI, Drug: FOLFOX regimen, Drug: IrinotecanThis is an open-label phase II study investigating the efficacy and safety of a bio-marker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line. Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be prospectively performed before each line of treatment, mCRC patients will be treated with cetuximab in combination with chemotherapy throughout three lines of therapy, as follows: * FOLFIRI plus cetuximab (first line); * FOLFOX plus cetuximab (second line); * irinotecan plus cetuximab (third line). If at progression after the first line or after the second line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with FOLFOX plus bevacizumab as second line of therapy, or with regorafenib or with trifluridine-tipiracil (investigator's choice) as third line therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically proven diagnosis of colorectal adenocarcinoma
- Diagnosis of metastatic disease
- RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis
- Measurable disease according to Response Evaluation Criteria in Solid Tumors RECIST criteria, vers.1.1)
- Male or female patients ≥ 18 years of age
Key exclusion criteria (20 listed)
- Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic acid,bevacizumab, trifluridine-tipiracil, regorafenib
- Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease
- Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix
- Pregnancy (exclusion to be ascertained by a beta hCG test)
- Breastfeeding
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 |
|---|---|---|
| CetuximabAlso: ErbituxI LINE: - FOLFIRI + cetuximab FOLFIRI: 200 mg L-folinic acid with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days. Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter II LINE: - FOLFOX + cetuximab FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days. Cetuximab: as I line THIRD LINE: - Irinotecan + cetuximab Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line | Drug | single arm |
| FOLFIRII LINE: - FOLFIRI + cetuximab FOLFIRI: 200 mg L-folinic acid given concurrently with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days. Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter | Drug | single arm |
| FOLFOX regimenAlso: FOLFOXII LINE: - FOLFOX + cetuximab FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days. Cetuximab: as I line | Drug | single arm |
| IrinotecanIII LINE: - Irinotecan + cetuximab Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line | Drug | single arm |
Primary outcome
RR
Time frame: up to 59 months
Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRCregimen over 3 treatment lines in patients with RAS/BRAF wild type (WT) mCRC at start of first line therapy
5 secondary outcomes
PFS
Time frame: from 8 weeks to 59 months (from the start of therapy until the first observation of disease progression or death due to any cause)
OS
Time frame: up to 59 months
AE
Time frame: from screening up to 59 months
EORTC Core Quality of Life questionnaire EORTC QLQ C30
Time frame: At screening, for each line of therapy at Week 4, at Week 25 of treatment start and at progression
DERMATOLOGY LIFE QUALITY INDEX (DLQI)
Time frame: at screening, for each line of therapy at Week 4, at Week 25 of treatment start and at progression
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 25 May 2025.
- Derived from this study: PubMed 36860319Martini G, Ciardiello D, Napolitano S, Martinelli E, Troiani T, Latiano TP, Avallone A, Normanno N, Di Maio M, Maiello E, Ciardiello F. Efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wild type tumors at start of first line: The CAPRI 2 GOIM trial. Front Oncol. 2023 Feb 13;13:1069370. doi: 10.3389/fonc.2023.1069370. eCollection 2023.
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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. This study is not recruiting at the moment.
Fortunato Ciardiello principal investigator
A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, FOLFIRI and FOLFOX regimen in people with Metastatic Colorectal Adenocarcinoma, run by University of Campania Luigi Vanvitelli at 25 sites in Italy.
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 18 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RR (time frame: up to 59 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05312398, which also lists 1 linked publication.
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 25 May 2025.