drugset / Trial / NCT06501053
Contact Radiotherapy for Rectal Cancer
Recruiting
110 enrolled
Alexander Valdman
Karolinska Institutet · collabUppsala University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).
Timeline
- Start
- 2025-03-03
- Primary completion
- 2030-04
- Completion
- 2032-11
Publications
- Background Gerard JP, Barbet N, Schiappa R, Magne N, Martel I, Mineur L, Deberne M, Zilli T, Dhadda A, Myint AS; ICONE group. Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):356-367. doi: 10.1016/S2468-1253(22)00392-2. Epub 2023 Feb 16.
- Nilsson PJ, Folkesson J, Marsk R, Radu C, Stratulat I, Blomqvist L, Martling A, Valdman A. Contact radiotherapy for rectal cancer (CORRECT): study protocol for a multicentre randomised phase II trial. BMJ Open. 2025 Apr 9;15(4):e100356. doi: 10.1136/bmjopen-2025-100356.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 900 mg/m2 | — |