NCT06402864

Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma

Multicenter Randomized Phase III Trial Evaluating Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Adult With Intermediate Low or Mid Rectal Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	contact X-ray brachytherapy (CXB)	3 fractions of contact X-ray brachytherapy (CXB) every two weeks before neoadjuvant chemo radiotherapy (nCRT).

Timeline

• Start date: 2024-03-26
• Primary completion: 2029-06-15
• Completion: 2030-06-15
• First posted: 2024-05-07
• Last updated: 2025-12-04

Locations

11 sites across 1 country: France