Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Ca… (NCT01804790) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer
France461 participantsStarted 2012-01
Plain-language summary
National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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
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 cer…