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NCT Number: NCT05902533

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Cincinnati Medical Center, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Capecitabine

Drug

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

mitomycin C

Drug

10 mg/m2 slow IV push Day 1 and 29

Primary outcomes

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

    Time frame: 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.

  2. Assess patient reported GI toxicity using PRO-CTCAE Diarrhea

    Time frame: 9 weeks post treatment

    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%.

Secondary outcomes

  1. Colostomy-Free-Survival - measured by follow up without colostomy

    Time frame: 3 years (Patients followed 3 years post Treatment)

    Colostomy-Free-Survival - Time from treatment completion to any colostomy or last follow up without colostomy.

  2. Disease Free Survival measured by digital rectal exam

    Time frame: 3 and 6 months post treatment

    Disease Free Survival - Failure to achieve complete response (CR) at 6 months or subsequent recurrence. There will be a documented clinical response assessment of the primary anal tumor primarily by using digital rectal exam at 3 and 6 months to define clinical complete response along with a review of imaging at 6 months. Any residual tumor at 6 months would be considered "failure to achieve a complete response" and would be considered a DFS event. Resolution of the primary tumor after chemoradiation and recurrence of tumor (any size) would be considered a DFS event. Persistence of disease in grossly enlarged lymph node (GTV Gross Nodes) at 6 months or resolution and then recurrence (any size) would be considered DFS event. New lesions in the elective nodal space or any other location will be considered a DFS event.

  3. Local Regional Recurrence

    Time frame: 6 months post treatment

    Local Regional Recurrence - All failures within the PTVs for the primary tumor, for the involved Lymph Nodes, or for the Elective Lymph Nodes, including both patients who failed to achieve CR at 6 months and those occurring more than 6 months after completion of chemoradiation after initial CR.

  4. Overall Survival - measured by survival or death at follow up

    Time frame: 3 years (Patients followed 3 years post Treatment)

    Overall Survival - Time from registration to death or last follow up

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

    Time frame: Measured during the 5.5 - 6 week treatment period

    Treatment breaks- The proportion of patients requiring a treatment break due to toxicity (more than 3 consecutive fractions missed) will be monitored and reported. In RTOG 0529, 50% of patients treated with standard nodal dose required a treatment break.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Acronym: REDEL

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Jun 15, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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