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

NCT05902533 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UCCC-GI-23-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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

Anal Cancer

Keywords

Toxicity Mitigation; Reduced Elective Nodal Dose

Outcome Measures

Primary Outcomes (2)

• Assess Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment

  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.

  90 days post treatment

• Assess patient reported GI toxicity using PRO-CTCAE Diarrhea

  PRO-CTCAE Diarrhea will be used to assess patient reported GI toxicity for the primary endpoint at weeks 3, 5, and 9 (approximately 1-month post-treatment). Any high grade PRO-CTCAE Diarrhea (frequently/almost constantly) in week 3-9 was reported in 71% of patients on a prior trial in this population (UC-GI-1601) with standard nodal dose. With n=33 at alpha =0.05 (actual alpha=0.033) and power=0.80, we can detect a reduction in the proportion of patients reporting any PRO-CTCAE high grade diarrhea (week 3, 5, 9) of at least 22.3%.

  9 weeks post treatment

Secondary Outcomes (5)

• Colostomy-Free-Survival - measured by follow up without colostomy

  3 years (Patients followed 3 years post Treatment)

• Disease Free Survival measured by digital rectal exam

  3 and 6 months post treatment

• Local Regional Recurrence

  6 months post treatment

• Overall Survival - measured by survival or death at follow up

  3 years (Patients followed 3 years post Treatment)

• Proportion of patients requiring a treatment break due to toxicity; measured by more than 3 consecutive fractions missed.

  Measured during the 5.5 - 6 week treatment period

Study Arms (1)

Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C

EXPERIMENTAL

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

Radiation: Radiation (reduced elective nodal dose (30.6 Gy); Drug: Capecitabine; Drug: Mitomycin c

Interventions

Capecitabine DRUG

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

Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C

Mitomycin c DRUG

10 mg/m2 slow IV push Day 1 and 29

Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C

Radiation (reduced elective nodal dose (30.6 Gy) RADIATION

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.

Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any prior pelvic radiation.
• 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.
• a. Note: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• Pregnant or breastfeeding women are excluded from this study.
• 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.
• Patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (3)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Radiation; Capecitabine; Mitomycin

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm prospective trial.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: August 14, 2023
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (3)