Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma
Trial Parameters
Brief Summary
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response. The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders. "Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).
Eligibility Criteria
INCLUSION CRITERIA FOR SCREENING 1. Written consent, 2. Patient who receive Folfirinox, 3. Patient aged over 18 years old, 4. World Health Organization (WHO) performance status ≥ 1, 5. Histologically confirmed diagnosis of adenocarcinoma of the rectum, 6. Distal part of the tumor from 1 to 12 cm from the upper part of the levator ani (dynamic rectal examination), 7. No unequivocal evidence on CT-Scan of established metastatic disease, 8. MRI evaluation of the locally advanced tumor before neoadjuvant chemotherapy: 1. Predictive CRM \< 2 mm 2. Or T3c-d (extending ≥ 5 mm beyond the muscularis propria) with extra mural venous invasion (EMVI) 3. Or T4a-b (except bone and sphincteric invasion). NON INCLUSION CRITERIA FOR SCREENING 1. Non measurable rectal tumor or not assessed by MRI before inclusion, 2. Ultra-low rectal tumor at diagnosis which imposes radiotherapy administration (inferior tumor pole less than 1 cm from the upper part of the levator ani). 3. Active cardiac disease includin