REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
NCT05902533 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2025-12-18
Summary
To determine the efficacy of reduced elective nodal radiation in anal cancer patients undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation.
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
-
825 mg/m2 BID (Oral Twice daily on days with RT)
- DRUG
-
Mitomycin c
10 mg/m2 slow IV push Day 1 and 29
Sponsors & Collaborators
-
University of Cincinnati
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-14
- Primary Completion
- 2026-08-14
- Completion
- 2029-08-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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