Status:
RECRUITING
Contact Radiotherapy for Rectal Cancer
Lead Sponsor:
Alexander Valdman
Collaborating Sponsors:
Uppsala University Hospital
Karolinska Institutet
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pre...
Detailed Description
The primary aim of this study is to determine whether a combination of CXB + SCRT is non-inferior to CXB + chemoradiotherapy (CRT) regarding the primary endpoint 2-year organ preservation rate. Additi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06501053
Start Date
March 3 2025
End Date
November 1 2032
Last Update
June 6 2025
Active Locations (2)
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1
Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
Stockholm, Solna, Sweden, 171 76
2
Uppsala University Hospital, Colorectal Surgery
Uppsala, Sweden, 751 85