NCT05902533Active, not recruitingPhase 2/3
REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
To determine the efficacy of reduced elective nodal radiation in anal cancer patients undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 5 Jun 2023
- Start date
- 14 Aug 2023
- Primary completion date
- 14 Aug 2026
- Lead sponsor
- University of Cincinnati
- NCT number
- NCT05902533
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 33
- From 14 Aug 2023 to the primary completion date, 14 Aug 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior pelvic radiation.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator.
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine.
- Patients with uncontrolled intercurrent illness that in the opinion of the investigator would prevent receipt of radiation or capecitabine.
- Note: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.
Other
- Pregnant or breastfeeding women are excluded from this study.
Who the study is looking for
- Age ≥18 years.
- Patients must have stage T1-4N+M0 or T3/T4N0M0 locally advanced anal cancer as evidenced by a PET scan AND either a CT with contrast of the abdomen/pelvis or an MRI with contrast of the pelvis. All imaging must be from within 60 days prior to registration.
- Note: Patients with T2N0 disease will be allowed if the primary tumor is \>4 cm. Patients with Stage I-T1N0M0 or Stage II-T2N0M0 (tumor ≤ 4cm) will be ineligible for participation.
- Patients with perianal cancer that is HPV associated (P16+) will be eligible if the tumor extends to the anal verge and the CTV will include the mesorectal, internal/external iliac, and inguinal lymph nodes.
- Patients with excision of the primary tumor but with node positive disease or residual disease at the primary if T3T4N0 will be eligible.
- ECOG performance status 0 or 1 (or Karnofsky ≥70, see Appendix A).
- Patients must be able to receive concurrent treatment with capecitabine and Mitomycin C in the opinion of the investigator.
- Creatinine Clearance must be \> 30 ml/min.
- Ability to understand and the willingness to sign a written informed consent document.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Ohio State University Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.