Contact radiotherapy for rectal cancer treatment
Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial
This study is testing a new treatment for early rectal cancer that combines a type of radiation therapy with a shorter course of treatment to see if it can help preserve organs and cause fewer side effects than standard options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Stockholm, Solna and 1 other locations) |
| Trial ID | NCT06501053 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a combination of Contact x-ray brachytherapy (CXB) and short-course radiotherapy (SCRT) in preserving organs for patients with early and early intermediate rectal cancer. Participants will be randomly assigned to receive either the standard treatment of CXB combined with chemoradiotherapy or the experimental treatment of CXB with SCRT. The primary goal is to determine if the new treatment is non-inferior in terms of the two-year organ preservation rate while potentially reducing side effects compared to existing therapies. This approach is particularly relevant for patients who may not tolerate more intensive treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above with operable adenocarcinoma of the rectum classified as cT1-cT3ab, N0-N1, and accessible for endocavitary contact X-ray brachytherapy.
Not a fit: Patients with inoperable rectal cancer, advanced tumor stages, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for rectal cancer patients, leading to better organ preservation and fewer side effects.
How similar studies have performed: While previous studies have shown promising outcomes with SCRT and CXB, this specific combination has not been tested in a randomized setting, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm, Solna and 1 other locations
- Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer — Stockholm, Solna, Sweden (Recruiting)
- Uppsala University Hospital, Colorectal Surgery — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Alexander Valdman, MD, PhD
- Email: alexander.valdman@regionstockholm.se
- Phone: +46 70 002 13 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.