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
Condition: Cancer of the Rectum
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT01804790
Phase: Phase 3
- Age: minimum 18 Years maximum 75 Years
- Gender: All
- Histologically 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
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (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
- 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.
View trial on ClinicalTrials.gov