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Cancer of the Rectum

Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer

Sponsored by UNICANCER

About this trial

Last updated 9 months ago

Study ID

PRODIGE 23 - UCGI 23

Status

Active, not recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status