ACTIVE_NOT_RECRUITING

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

Conditions

Anal Cancer Toxicity Mitigation Reduced Elective Nodal Dose

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-08-14

Study Completion:2029-08-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05902533

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. 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.

Inclusion Criteria

Exclusion 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.

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.
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.

Contacts and Locations

Study Locations (Sites)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

United States

Ohio State University Medical Center

Columbus, Ohio, 43210

United States

University of Vermont

Burlington, Vermont, 05405

United States

Collaborators and Investigators

Sponsor: University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-14

Study Completion Date2029-08-14

Study Record Updates

Study Start Date2023-08-14

Study Completion Date2029-08-14

Terms related to this study

Keywords Provided by Researchers

Toxicity Mitigation
Reduced Elective Nodal Dose

Additional Relevant MeSH Terms

Anal Cancer