NCT06501053Recruiting
Contact Radiotherapy for Rectal Cancer
Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 3 Jul 2024
- Start date
- 3 Mar 2025
- Primary completion date
- Apr 2030
- Lead sponsor
- Alexander Valdman
- Diseases
- Colorectal cancer
- NCT number
- NCT06501053
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 3 Mar 2025 to the primary completion date, Apr 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic irradiation
- Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy
- Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
Other illness
- Simultaneous progressive cancer
- 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
Other
- 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)
- Tumor with extramural vascular invasion
- Poorly differentiated tumor
- 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
- Total DPD deficiency
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Uppsala University Hospital, Colorectal Surgery Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.