Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Not Applicable
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 preservation for early and early intermediate rectal cancer (cT1-3abN1).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
RECRUITING
Stockholm
Uppsala University Hospital, Colorectal Surgery
RECRUITING
Uppsala
Contact Information
Primary
Alexander Valdman, MD, PhD
alexander.valdman@regionstockholm.se
+46 70 002 13 17
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2032-11
Participants
Target number of participants: 110
Treatments
Active_comparator: CXB + CRT
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).
Experimental: CXB + SCRT
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).
Related Therapeutic Areas
Sponsors
Leads: Alexander Valdman
Collaborators: Karolinska Institutet, Uppsala University Hospital

This content was sourced from clinicaltrials.gov