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Anti-metabolites
Reduced-Dose Radiation + Chemotherapy for Anal Cancer (REDEL Trial)
Phase 2 & 3
Recruiting
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years (patients followed 3 years post treatment)
Awards & highlights
REDEL Trial Summary
This trial tests if reducing radiation on lymph nodes for anal cancer patients receiving chemo & radiation can reduce side effects.
Who is the study for?
This trial is for adults over 18 with locally advanced anal cancer, confirmed by PET scan and CT/MRI within the last 60 days. Eligible patients have specific stages of cancer (T1-4N+M0 or T3/T4N0M0) and may include those with large tumors (>4 cm) or HPV-related perianal cancer extending to the anal verge. Participants must be physically able to undergo treatment, have a creatinine clearance >30 ml/min, and understand consent.Check my eligibility
What is being tested?
The REDEL Trial is testing whether reducing the radiation dose to elective nodal areas (to 30.6 Gy), while undergoing chemotherapy with Capecitabine and Mitomycin C, can lessen toxicity without compromising effectiveness in treating anal cancer compared to standard radiation doses.See study design
What are the potential side effects?
Potential side effects from reduced-dose radiation may include skin irritation, fatigue, gastrointestinal issues like nausea or diarrhea. Chemotherapy with Capecitabine and Mitomycin C might cause mouth sores, low blood cell counts increasing infection risk, heartburn, hand-foot syndrome.
REDEL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years (patients followed 3 years post treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years (patients followed 3 years post treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment
Assess patient reported GI toxicity using PRO-CTCAE Diarrhea
Secondary outcome measures
Colostomy-Free-Survival - measured by follow up without colostomy
Disease Free Survival measured by digital rectal exam
Local Regional Recurrence
+2 moreREDEL Trial Design
1Treatment groups
Experimental Treatment
Group I: Reduced Elective Dose + Concurrent Capecitabine/Mitomycin CExperimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Mitomycin c
2021
Completed Phase 3
~150
Find a Location
Who is running the clinical trial?
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,361 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or able to carry out light work.I am 18 years old or older.I have had radiation therapy in the pelvic area before.I do not have any severe illnesses that would stop me from receiving radiation or capecitabine.I am HIV-positive, on treatment, and my viral load is undetectable.My cancer was removed but it had spread to my lymph nodes or was large at the primary site.I do not have an active autoimmune disease needing treatment.I can be treated with capecitabine and Mitomycin C together.My cancer is at an early stage but the tumor is larger than 4 cm.My perianal cancer is HPV-related and affects areas near the anal opening, including certain lymph nodes.My anal cancer is locally advanced but hasn't spread to distant parts.
Research Study Groups:
This trial has the following groups:- Group 1: Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team currently admitting participants for this trial?
"As per the clinicaltrials.gov page, this research project is not presently seeking participants. Although it was initially listed on July 5th 2023 and most recently modified on June 5th 2023, no patients are being sought at present. In contrast, 64 other investigations are actively recruiting subjects right now."
Answered by AI
What are the primary goals of this medical study?
"The primary objective of this 90 day study is to gauge the gastrointestinal toxicity of patients via PRO-CTCAE Diarrhea. Secondary outcomes include Disease Free Survival - Failure to achieve complete response (CR) at 6 months or subsequent recurrence, documented clinical response assessment primarily through digital rectal exam at 3 and 6 months , Overall Survival measured by survival/death follow up, and a Proportion of patients requiring treatment break due to toxicity exceeding three consecutive fractions missed."
Answered by AI
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