Locally Advanced Rectal CancerPhase 2ShorTripNCT05253846
Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29
A Phase 2 study testing Irinotecan, Oxaliplatin and Lederfolin in people with Locally Advanced Rectal Cancer, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.
Trial summary
The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Irinotecan, Oxaliplatin and Lederfolin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2022to 30 Oct 2028
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent to study procedures and to translational analyses;
- Age 18-70 years;
- Histologically proven diagnosis of rectal adenocarcinoma;
- Patients with locally advanced rectal cancer defined by the presence of at least one of the following features:
- cN2 (defined as at least 4 positive lymphnodes at pelvic MRI)
- cT4
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- tumor extending to within 1 mm of or beyond mesorectal fascia (i.e., circumferential radial margin threatened or involved)
- cT3, N1
- Distal border of the tumour located between 5 and 12 cm from the anal verge (as measured by pelvic MRI);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1;
- No evidence of metastatic disease by total body CT-scan;
- Available tumour samples at baseline (archival biopsy);
- Tumour amenable to curative resection (including pelvic exenteration);
- No history of invasive rectal malignancy, regardless of disease-free interval;
- No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer;
- No clear involvement of the pelvic side walls by imaging;
- Life expectancy of at least 5 years (excluding diagnosis of cancer);
- Hematopoietic function: absolute neutrophil count ≥ 1,500/mm3; platelet count
- ≥100,000/mm3; haemoglobin level ≥ 9 g/dL;
- Liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN); alkaline phosphatase ≤ 2 times ULN; AST ≤ 2 times ULN;
- Renal function: creatinine clearance > 50 mL/min or serum creatinine 1.5 x UNL; no renal disease that would preclude study treatment or follow-up;
- Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.
- However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; - Subjects and their partners must be willing to avoid pregnancy during the trial. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception.
- Contraception, starting during study screening visit throughout the study period up to 180 days after the last dose of chemotherapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject;
- Will and ability to comply with the protocol.
Who cannot join
- Previous history of malignancy within the last 5 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ;
- Patients with radiological evidence of distant metastases;
- Previous pelvic radiation therapy;
- Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;
- Previous treatment with fluoropyrimidine and/or oxaliplatin and/or irinotecan;
- Patient with complete dihydropyrimidine dehydrogenase (DPYD) deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT);
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- Treatment with any investigational drug within 30 days prior to enrolment or 2 investigational agent half-lives (whichever is longer);
- Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration;
- Clinically significant (e.g. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication;
- Active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic);
- Partial or total colectomy;
- Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study and until 180 days after the last trial treatment;
- Known hypersensitivity to fluorouracil, oxaliplatin or irinotecan;
- Psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation;
- Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration;
- Withdrawal of the consent to take part to the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa
Pisa, 56126
About this study
Official title: Phase II Study of Short-course Radiotherapy Followed by Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: the ShorTrip Study
The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.
Read the detailed description
This is a prospective, open-label, multicentre, phase II single arm trial. Eligible patients with middle-high LARC will receive short-course radiotherapy followed by consolidation chemotherapy with FOLFOXIRI and surgery.
The primary objective of this trial is to evaluate the rate of complete pathologic response (pCR)
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Irinotecan, Oxaliplatin, Lederfolin, 5-Fluorouracil, Short-course radiotherapy
- Keywords
- FOLFOXIRI, Locally advanced rectal cancer, Short-course radiotherapy, Total neoadjuvant strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
chemotherapy treatment
OxaliplatinDrug
chemotherapy treatment
LederfolinDrug
treatment
5-FluorouracilDrug
chemotherapy treatment
Short-course radiotherapyRadiation
RT
TMEProcedure or surgery
surgery
| Study group | Role | What they receive |
|---|---|---|
| SCRT--> FOLFOXIRI--> SURGERY | Experimental | SHORT-COURSE RT
FOLFOXIRI
* IRINOTECAN 165 mg/sqm iv over 60 minutes, day 1 followed by
* OXALIPLATIN 85 mg/sqm iv over 2 hours, day 1 in two-way with
* LEDERFOLIN 200 mg/sqm iv over 2 hours, day 1 followed by
* 5-FLUOROURACIL 3200 mg/sqm 48 h-continuous infusion, starting on day 1. The chemotherapy treatment will be repeated every 2 weeks up to 8 cycles.
Surgery with TME should be performed after 4 weeks after the last cycle of chemotherapy Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: Lederfolin; Drug: 5-Fluorouracil; Radiation: Short-course radiotherapy; Procedure: TME |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete pathologic response (pCR)
Pathological complete response rate, defined as the percentage of patients, relative to the total of enrolled subjects, with the absence of residual tumour cells in the resected specimens. pCR will be assessed by tumour regression grade according to Dworak et al, at the histopathological exam
Measured: 30 months
Secondary outcomes (16)
Overall toxicity rate
Overall toxicity rate, defined as the percentage of patients, relative to the total of enrolled subjects, who receive radiotherapy and at least one cycle of chemotherapy, experiencing any adverse event, according the RTOGTC during SCRT, and according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the consolidation chemotherapy
Measured: 30 months
G3/4 toxicity rate
G3/4 toxicity rate, is defined as the percentage of patients, relative to the total of enrolled subjects, who receive radiotherapy and at least one cycle of chemotherapy, experiencing a specific adverse event of grade 3/4, according the RTOGTC during SCRT, and according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the consolidation chemotherapy.
Measured: 30 months
R0 Resection Rate
R0 Resection Rate is defined as the percentage of patients, relative to the total of enrolled subjects, undergoing R0 resection of primary tumour. R0 surgery is defined as microscopically margin-negative resection at the histopatological exam
Measured: 30 months
Failure-free survival (FFS)
Failure-free survival (FFS) is defined as the time from enrollment to one of the following events: non-radical surgery (non R0/R1) of the primary tumour, intrapelvic recurrence after R0/1 resection of the primary tumour, distant relapse, second primary tumour or death from any cause, whichever occurred first. The determination of disease progression will be based on investigator-reported measurements. Patients who are alive without having one of the above events at the end of the study will be censored at their last radiological assessment
Measured: 7 years
Overall Survival (OS)
Overall Survival (OS) is defined as the time from enrolment to death from any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive
Measured: 7 years
Time to distant metastases
Time to distant metastases, is defined as the time from enrolment to the radiological evidence of distant metastases. The determination of the evidence of distant metastases will be based on investigator-reported measurements. Patients who are died or alive without having distant metastases at the end of the study will be censored at the date of death or their last radiological assessment, respectively
Measured: 7 years
Time to locoregional failure
Time to locoregional failure is defined as the time from the enrolment to non-radical surgery of the primary tumour (non R0/R1 resection) or intrapelvic recurrence after R0/1 resection of the primary tumour. The determination of the intrapelvic recurrence will be based on investigator-reported assessment. Patients who are died or alive without having non-radical surgery or intrapelvic recurrence at the end of the study will be censored at the date of death or at their last radiological assessment
Measured: 7 years
Clinical complete response (cCR) rate
Clinical complete response (cCR) rate, defined as the percentage of patients, relative to the total of enrolled subjects, with the absence of residual tumour (cT0cN0) at the radiological and endoscopic staging after neoadjuvant treatment.
Measured: 30 months
Major pathological response (MPR) rate
Major pathological response (MPR) rate, defined as the percentage of patients, relative to the total enrolled subjects, achieving TRG1-2 sec Mandard or TRG3-4 sec Dworak at the histopathological exam
Measured: 30 months
Surgical mortality
Surgical mortality, defined as the percentage of patients, relative to the total of enrolled subjects, experiencing death within 30 days after the surgery
Measured: 30 months
Surgical morbidities
Surgical morbidities, defined as the percentage of patients, relative to the total of enrolled subjects, experiencing any post-operative complications within 30 days after the surgery
Measured: 30 months
Quality of Life (QoL)
Quality of Life, (QoL) assessed using the EORTC QLQ-C30, will be evaluate at specific time-points (baseline, after radiotherapy, and chemotherapy, after surgery and during follow-up) and will be assessed through descriptive summary statistics
Measured: until 1 year after surgery
Quality of Life (QoL)
Quality of Life, (QoL) assessed using the EORTC QLQ-CR29, will be evaluate at specific time-points (baseline, after radiotherapy, and chemotherapy, after surgery and during follow-up) and will be assessed through descriptive summary statistics
Measured: until 1 year after surgery
Quality of Life (QoL)
Quality of Life, (QoL) assessed using the EuroQol EQ-5D questionnaires, will be evaluate at specific time-points (baseline, after radiotherapy, and chemotherapy, after surgery and during follow-up) and will be assessed through descriptive summary statistics
Measured: until 1 year after surgery
Rectal Continence
Rectal Continence, assessed using LARS scores, will be evaluate at specific time-points (baseline, after radiotherapy, and chemotherapy, after surgery and during follow-up) and will be assessed through descriptive summary statistics
Measured: until 180 days after the ileostomy closure surgery
Rectal Continence
Rectal Continence, assessed using St. Mark Continence scores, will be evaluate at specific time-points (baseline, after radiotherapy, and chemotherapy, after surgery and during follow-up) and will be assessed through descriptive summary statistics
Measured: until 180 days after the ileostomy closure surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start25 Jan 2022
- Primary completion5 Jan 2025
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Moretto, MD, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253846
- Sponsor's protocol ID
- ShorTrip
- Acronym
- ShorTrip
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Short-course Radiotherapy Followed by Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: the ShorTrip Study
- ClinicalTrials.gov ID
- NCT05253846
- Acronym / sponsor ID
- ShorTrip / ShorTrip
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- FOLFOXIRI, Locally advanced rectal cancer, Short-course radiotherapy, Total neoadjuvant strategy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Gruppo Oncologico del Nord-OvestUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 24 Feb 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.
The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.
Detailed description
This is a prospective, open-label, multicentre, phase II single arm trial. Eligible patients with middle-high LARC will receive short-course radiotherapy followed by consolidation chemotherapy with FOLFOXIRI and surgery.
The primary objective of this trial is to evaluate the rate of complete pathologic response (pCR)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCRT--> FOLFOXIRI--> SURGERY | Experimental | Drug: Irinotecan, Drug: Oxaliplatin, Drug: Lederfolin, Drug: 5-Fluorouracil, Radiation: Short-course radiotherapy, Procedure: TMESHORT-COURSE RT FOLFOXIRI * IRINOTECAN 165 mg/sqm iv over 60 minutes, day 1 followed by * OXALIPLATIN 85 mg/sqm iv over 2 hours, day 1 in two-way with * LEDERFOLIN 200 mg/sqm iv over 2 hours, day 1 followed by * 5-FLUOROURACIL 3200 mg/sqm 48 h-continuous infusion, starting on day 1. The chemotherapy treatment will be repeated every 2 weeks up to 8 cycles. Surgery with TME should be performed after 4 weeks after the last cycle of chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Written informed consent to study procedures and to translational analyses;
- Age 18-70 years;
- Histologically proven diagnosis of rectal adenocarcinoma;
- Patients with locally advanced rectal cancer defined by the presence of at least one of the following features:
- Distal border of the tumour located between 5 and 12 cm from the anal verge (as measured by pelvic MRI);
Key exclusion criteria (16 listed)
- Previous history of malignancy within the last 5 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ;
- Patients with radiological evidence of distant metastases;
- Previous pelvic radiation therapy;
- Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;
- Previous treatment with fluoropyrimidine and/or oxaliplatin and/or irinotecan;
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 |
|---|---|---|
| Irinotecanchemotherapy treatment | Drug | SCRT--> FOLFOXIRI--> SURGERY |
| Oxaliplatinchemotherapy treatment | Drug | SCRT--> FOLFOXIRI--> SURGERY |
| Lederfolintreatment | Drug | SCRT--> FOLFOXIRI--> SURGERY |
| 5-Fluorouracilchemotherapy treatment | Drug | SCRT--> FOLFOXIRI--> SURGERY |
| Short-course radiotherapyRT | Radiation | SCRT--> FOLFOXIRI--> SURGERY |
| TMEsurgery | Procedure or surgery | SCRT--> FOLFOXIRI--> SURGERY |
Primary outcome
complete pathologic response (pCR)
Time frame: 30 months
Pathological complete response rate, defined as the percentage of patients, relative to the total of enrolled subjects, with the absence of residual tumour cells in the resected specimens. pCR will be assessed by tumour regression grade according to Dworak et al, at the histopathological exam
16 secondary outcomes
Overall toxicity rate
Time frame: 30 months
G3/4 toxicity rate
Time frame: 30 months
R0 Resection Rate
Time frame: 30 months
Failure-free survival (FFS)
Time frame: 7 years
Overall Survival (OS)
Time frame: 7 years
Time to distant metastases
Time frame: 7 years
Time to locoregional failure
Time frame: 7 years
Clinical complete response (cCR) rate
Time frame: 30 months
Major pathological response (MPR) rate
Time frame: 30 months
Surgical mortality
Time frame: 30 months
Surgical morbidities
Time frame: 30 months
Quality of Life (QoL)
Time frame: until 1 year after surgery
Quality of Life (QoL)
Time frame: until 1 year after surgery
Quality of Life (QoL)
Time frame: until 1 year after surgery
Rectal Continence
Time frame: until 180 days after the ileostomy closure surgery
Rectal Continence
Time frame: until 180 days after the ileostomy closure surgery
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 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Roberto Moretto, MD principal investigator
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, Oxaliplatin and Lederfolin in people with Locally Advanced Rectal Cancer, run by Gruppo Oncologico del Nord-Ovest at 1 site 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 25 inclusion and 16 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
complete pathologic response (pCR) (time frame: 30 months). 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 24 Jul 2026.