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 3.1 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
3 fractions of contact X-ray brachytherapy (CXB) every two weeks before neoadjuvant chemo radiotherapy (nCRT).
Institut Sainte Catherine
Avignon, France, France
RECRUITINGCentre Léon Bérard
Lyon, France, France
RECRUITINGCentre de radiotéhrapie Charcot
Lyon, France, France
RECRUITINGHôpital Européen
Marseille, France, France
RECRUITINGCentre d'oncologie et de radiothérapie
Mâcon, France, France
RECRUITINGCentre de Haute Energie
Nice, France, France
RECRUITINGCentre Antoine Lacassagne
Nice, France, France
RECRUITINGCHU de Saint Etienne
Saint-Etienne, France, France
RECRUITINGInstitut de cancérologie de l'Ouest
Saint-Herblain, France, France
RECRUITINGInstitut Gustave Roussy
Villejuif, France, France
RECRUITING...and 1 more locations
Survival with organ preservation
defined as a rectum intact, owing to: * no radical TME, * no locoregional regrowth unless amenable to limited curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma, or a stoma owing to toxicities and/or poor functional outcomes).
Time frame: at the end of the study,15 months after the first inclusion
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