Adult With Intermediate Low or Mid Rectal Adenocarcinoma Clinical Trial
Official title:
Multicenter Randomized Phase III Trial Evaluating Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
Indication : Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation. Primary objective is to assess efficacy of contact X-ray brachytherapy (CXB) in addition to TNT in order to increase survival with organ preservation (OP), in selected intermediate risk group of rectal adenocarcinomas (size from 3.5 to 6 cm, cT2N1 or T3N0-1, M0).
It is an open label phase III randomized controlled clinical trial comparing 2 arms: - Control arm A consists in TNT regimen, with an induction chemotherapy Modified FOLFIRINOX (mFOLFIRINOX) 6 cycles over 12 weeks, followed by nCRT 50 Gy over 5 weeks with concomitant capecitabine (CAP50 Gy). - Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT. Clinical, endoscopic and radiological evaluation will be performed 7 weeks after the end of nCRT in both arms: - In case of cCR, local excision or surveillance will be proposed to patients regarding center choice - In the absence of cCR patients will be treated by TME, followed by adjuvant chemotherapy (mFOLFOX 6 cycles or capecitabine 3 cycles over 12 weeks). ;