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RECRUITING
NCT06501053
NA

Contact Radiotherapy for Rectal Cancer

Sponsor: Alexander Valdman

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-03-03

Completion Date

2032-11

Last Updated

2025-06-06

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Radiotherapy

45/50 Gy (1.8/2 Gy/fraction/5 weeks)

RADIATION

Short-course radiotherapy

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

RADIATION

Contact x-ray brachytherapy

90Gy/3 fractions/4 weeks

DRUG

Chemotherapy

Capecitabine (900 mg/m2 bid, on radiation days)

Locations (2)

Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer

Stockholm, Solna, Sweden

Uppsala University Hospital, Colorectal Surgery

Uppsala, Sweden