Clinical trial · Interventional
REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
NCT05902533CI-TRIAL-00099198REDELactive not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the efficacy of reduced elective nodal radiation in anal cancer patients undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Mitomycin c | Drug | Mitomycin | ALIAS |
| Radiation (reduced elective nodal dose (30.6 Gy) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C
- description
- Reduced elective nodal dose (30.6 Gy); (28- 30 fractions given M-F for approximately 5.5 to 6 weeks) Capecitabine 825 mg/m2 BID on days with RT Mitomycin C 10 mg/m2 slow IV push Days 1 and 29
- interventionNames
- Radiation: Radiation (reduced elective nodal dose (30.6 Gy)
- Drug: Capecitabine
- Drug: Mitomycin c
Primary outcomes (2)
- measure
- Assess Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment
- timeFrame
- 90 days post treatment
- description
- Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment. In patients treated with IMRT enrolled to NRG/RTOG 0529, the mean GI/GU/Derm/Hem TI was 3.858 (SD=0.892) assessed during this time period with standard nodal dose using a simultaneous integrated boost technique. Thirty-three patients will allow an effect size of 0.4 with 80% power and one-sided alpha of 0.05. This effect size is larger than the difference in toxicity observed compared to the historic standard of 3D-conformal radiation with IMRT (current standard) and thus felt to represent a clinically meaningful difference. The CTCAE Toxicity index will be determined for all Dermatologic, Gastrointestinal, Genitourinary, and hematologic events within 90 days from treatment initiation that are possible, probably, or definitely attributable to treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years. 2. 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. 1. 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. 2. 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. 3. Patients with excision of the primary tumor but with node positive disease or residual disease at the primary if T3T4N0 will be eligible. 3. ECOG performance status 0 or 1 (or Karnofsky ≥70, see Appendix A). 4. Patients must be able to receive concurrent treatment with capecitabine and Mitomycin C in the opinion of the investigator. 5. Creatinine Clearance must be \> 30 ml/min. 6. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Any prior pelvic radiation. 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine. 3. Patients with uncontrolled intercurrent illness that in the opinion of the investigator would prevent receipt of radiation or capecitabine. a. Note: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 4. Pregnant or breastfeeding women are excluded from this study. 5. 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. 6. Patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.
References
Publications (0)
Data not yet available
No reference posted for this study.