Multicenter Phase 2 Trial: a Tailored Strategy for Locally Advanced Rectal Carcinoma

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the tailored management of locally advanced rectal carcinoma can improve the oncologic and functional outcome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Capecitabine; Folfirinox

Criteria

Inclusion Criteria:

• Histologically confirmed rectal carcinoma

• Primary tumor evaluated by pelvic MR Imaging:

i) iT3 ≥c tumors, with MRI showing a predictive CRM ≤ 2 mm or a EMS (Extra Mural Spread) ≥ 5 mm

ii) Resectable iT4 tumors (only randomized within the "poor responders" group)

iii) Any T tumors with MRI showing a predictive CRM ≤ 1 mm

• No detectable metastases: Thorax-abdomen-pelvic CT-scan

• Patient ≥ 18 years

• ECOG Performance Status 0-1-2

• Patient information and written informed consent form signed

• Patient who can receive radiotherapy and chemotherapy

• Negative pregnancy test in women of childbearing potential

• Patient covered by a Social Security system

• Hematology : Haemoglobin ≥ 9 g/dL, WBC ≥ 4000/mm3, neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L

• Hepatic function : total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN, Alkaline phosphatases ≤ 3 x ULN

• Renal function : creatinine ≤ 1.25 x ULN or creatinine clearance ≥ 60 ml/min

Exclusion Criteria:

• Indication for immediate surgery

• Primary tumor not measured at the MRI before inclusion

• Previous pelvic radiotherapy

• Contraindication to radiotherapy and/or chemotherapy

• Severe renal or liver impairment

• Cardiac and/or coronary disease which could contraindicate 5-Fu administration

• Active infectious disease

• Peripheral sensitive neuropathy

• History of prior cancer (except if it was cured more than 5 years ago, and if complete remission)

• Patient (male or female) of reproductive potential not using an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment

• Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule

• Fertile female patient not using adequate contraception, or breast-feeding woman