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ACTIVE NOT RECRUITING
NCT05902533
PHASE2/PHASE3

REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation

Sponsor: University of Cincinnati

View on ClinicalTrials.gov

Summary

To determine the efficacy of reduced elective nodal radiation in anal cancer patients undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2023-08-14

Completion Date

2029-08-14

Last Updated

2025-12-18

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Radiation (reduced elective nodal dose (30.6 Gy)

28-30 fractions Monday through Friday of intended chemoradiation depending on the total dose required (50.4-54 Gy) which will occur over approximately 5.5 to 6 weeks.

DRUG

Capecitabine

825 mg/m2 BID (Oral Twice daily on days with RT)

DRUG

Mitomycin c

10 mg/m2 slow IV push Day 1 and 29

Locations (3)

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Vermont

Burlington, Vermont, United States