- Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer
18 Years
75 Years
Both
Cancer of the Rectum
Trial Information
- Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer
Methodology This is a biomedical research, national, multicenter, open-label randomized,
2-arm phase III superiority trial, comparing neoadjuvant CT with mFolfirinox then
preoperative CRT, versus immediate preoperative CRT, in patients with locally advanced
rectal cancer Randomized Phase III study with stopping rules Stratification : center,
gender, tumor location in the rectum (< 6 cm from anal verge versus ≥ 6 cm), initial stage
(cT3 vs cT4, and cN0 vs cN+)
Inclusion Criteria:
- Histogically proven rectal adenocarcinoma
- Stages cT3 with risk of local recurrence or cT4, M0 and for which a multidisciplinary
meeting recommend preoperative CRT
- Resectable tumor, or considered as potentially resectable after CRT
- No distant metastases
- Patient eligible for surgery
- Patient aged from 18 to 75 years
- WHO/ECOG performance status 0/2.
- No heart failure or coronary heart disease symptoms (even controlled).
- No peripheral neuropathy > grade 1
- No prior radiotherapy of the pelvis for any reason and no previous CT
- No major comorbidity that may preclude the delivery of treatment and no active
infection (HIV or chronic hepatitis B or C).
- Adequate contraception in fertile patients.
- Adequate hematologic function
- Adequate hepatic function
- Signed written informed consent
Exclusion Criteria:
- Metastatic disease
- Unresectable rectal cancer, including prostatic involvement or extension to pelvic
floor muscles
- Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert
disease or genotype UGT1A1
- Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
- Medical history of angina pectoris or myocardial infarction
- Progressive active infection or any other severe medical condition that could
jeopardize treatment administration
- Other concomitant cancer, or medical history of cancer other than treated in situ
cervical carcinoma or basocellular carcinoma or spinocellular carcinoma
- Patient included in another clinical trial testing an investigational agent.
- Pregnant or breast-feeding woman.
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol or follow-up schedule.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease-free survival
Outcome Description:
To compare the 3-year disease-free survival between the investigational arm and the control arm.
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Thierry CONROY, PROF
Investigator Role:
Principal Investigator
Investigator Affiliation:
centre Alexis Vautrin les Nancy
Authority:
France: ANSM - French Health Products Safety Agency
Study ID:
PRODIGE 23
NCT ID:
NCT01804790
Start Date:
January 2012
Completion Date:
January 2022
Related Keywords:
- Cancer of the Rectum
- rectum
- cancer
- locally advanced
- Rectal Neoplasms
Name | Location |
|---|
