Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
Recruiting
Phase 3
Interventional Study
Adult With Intermediate Low or Mid Rectal Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 212 (estimated)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient with histologically proven rectal adenocarcinoma
* Intermediate risk factors: size ≥ 3.1 cm and ≤ 6 cm, \< 66% circumference, cT2N1 or T3N0-1, M0 at diagnostic.
* Accessible by digital rectal exam, distal or middle rectum (\<11 cm from anal verge), not significantly in…
Contacts