Actively Recruiting
Contact Radiotherapy for Rectal Cancer
Led by Alexander Valdman · Updated on 2025-06-06
110
Participants Needed
2
Research Sites
400 weeks
Total Duration
On this page
Sponsors
A
Alexander Valdman
Lead Sponsor
U
Uppsala University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Contact Radiotherapy for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adenocarcinoma of the rectum classified as cT1-cT3ab, less than 5 cm largest diameter and less than half circumference (MRI staging), N0-N1 (up to 3 nodes less than 8 mm 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 or less
- 18 years or above
- No comorbidity preventing treatment
- Patient having read the information note and having signed the informed consent
- Follow-up possible
You will not qualify if you...
- Inoperable patient
- T3cd, T4, tumor size 5 cm or more, involvement of more than half of the bowel circumference
- Distance from the lower tumor border to the anal verge greater than 10 cm
- N2-status at diagnosis or N1 with any node 8 mm diameter or more
- 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 mesorectal fascia
- Patient unable to receive CXB or CRT
- Any significant concurrent medical illness that would preclude protocol therapy
- History of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions interfering with study compliance
- Concurrent enrollment in another clinical trial using investigational anti-cancer treatment within 28 days prior to first dose
- Total DPD deficiency
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
Stockholm, Solna, Sweden, 171 76
Actively Recruiting
2
Uppsala University Hospital, Colorectal Surgery
Uppsala, Sweden, 751 85
Actively Recruiting
Research Team
A
Alexander Valdman, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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