Clinical trial · Interventional
Contact Radiotherapy for Rectal Cancer
Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial
NCT06501053CI-TRIAL-00121155CORRECTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Contact x-ray brachytherapy | Radiation | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Short-course radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CXB + CRT
- description
- Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and chemoradiotherapy (CRT) 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days).
- interventionNames
- Radiation: Radiotherapy
- Radiation: Contact x-ray brachytherapy
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- CXB + SCRT
- description
- Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and a short-course radiotherapy (SCRT) (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days).
- interventionNames
- Radiation: Short-course radiotherapy
- Radiation: Contact x-ray brachytherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the rectum classified as: * cT1-cT3ab, \< 5 cm largest diameter and \< ½ circumference (MRI staging), N0-N1 (\<= 3 nodes \< 8mm diameter), M0 * Performance status (ECOG) 0-1 * Operable patient * Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm * 18 years or above * No comorbidity preventing treatment * Patient having read the information note and having signed the informed consent * Follow-up possible Exclusion Criteria: * Inoperable patient * T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference * Distance from the lower tumor border to the anal verge \>10 cm * N2-status at diagnosis or N1 with any node\>= 8 mm diameter * Patient presenting with metastasis at diagnosis (M1) * Previous pelvic irradiation * Tumor with extramural vascular invasion * Poorly differentiated tumor * Simultaneous progressive cancer * Tumor invading external anal sphincter or growth within 1 mm of the levator * Tumor within 1 mm from MRF (mesorectal fascia) * Patient unable to receive CXB or CRT * Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy * Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol * Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment * Total DPD deficiency
References
Publications (2)
- BACKGROUNDGerard 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. PMID 36801007
- DERIVEDNilsson 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. PMID 40204311