NCT05902533

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multi-center, single arm prospective trial to evaluate whether reduced elective nodal dose (30.6 Gy) reduces toxicity as defined by the CTCAE Toxicity Index compared to historic patients treated with standard nodal dose on NRG/RTOG0529 and patient reported GI toxicity using the validated PRO-CTCAE scale for diarrhea compared to historic patients treated on UC-GI-1601.

Conditions

• Anal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-14
• Primary completion: 2026-08-14
• Completion: 2029-08-14
• First posted: 2023-06-15
• Last updated: 2025-12-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study