RecruitingPhase 3NCT06402864

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


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

212 participants

Start Date

Mar 26, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 clinical trial tests whether adding contact X-ray brachytherapy (CXB) — a localized radiation technique applied directly inside the rectum — to standard total neoadjuvant therapy (chemotherapy followed by radiation) can increase the chances of preserving the rectum and avoiding surgery in patients with intermediate-stage rectal cancer. Standard treatment (the control arm) uses chemotherapy (mFOLFIRINOX) followed by chemoradiation, while the experimental arm adds three sessions of CXB between these steps. Adults 18 and older with a confirmed rectal adenocarcinoma measuring 3.1–6 cm, at a specific stage (cT2N1 or T3N0-1, no distant spread), and located within 11 cm of the anal opening who are about to start or already on mFOLFIRINOX may be eligible. Participation involves additional CXB sessions and clinical, imaging, and endoscopic evaluations to assess tumor response. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONcontact X-ray brachytherapy (CXB)

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


Locations(11)

Institut Sainte Catherine

Avignon, France, France

Centre Léon Bérard

Lyon, France, France

Centre de radiotéhrapie Charcot

Lyon, France, France

Hôpital Européen

Marseille, France, France

Centre d'oncologie et de radiothérapie

Mâcon, France, France

Centre de Haute Energie

Nice, France, France

Centre Antoine Lacassagne

Nice, France, France

CHU de Saint Etienne

Saint-Etienne, France, France

Institut de cancérologie de l'Ouest

Saint-Herblain, France, France

Institut Gustave Roussy

Villejuif, France, France

Orlam-Bayard

Villeurbanne, France, France

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NCT06402864