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Contact Radiotherapy for Rectal Cancer

NCT06501053 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-06-06

No results posted yet for this study

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).

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)

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Alexander Valdman

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2030-04-30
Completion
2032-11-30

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06501053 on ClinicalTrials.gov