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Radiation Therapy
Adaptive Radiation for Anal Cancer
N/A
Recruiting
Led By Lisa Kachnic, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following the completion of chemoradiation
Awards & highlights
Study Summary
This trial looks at using tailored radiation treatment for locally advanced anal cancer. Daily plans are used to maximize dose to the tumor and minimize dose to surrounding organs.
Who is the study for?
This trial is for adults with advanced anal squamous cell cancer, who are in good health otherwise and have not had prior treatments for this cancer. They must be able to perform daily activities without significant assistance (ECOG ≤2) and agree to use contraception during the study.Check my eligibility
What is being tested?
The study tests a new approach using AI-guided radiation therapy tailored daily, combined with chemotherapy drugs like 5-Fluorouracil, Capecitabine, or Mitomycin-C. It aims to improve targeting of the tumor while protecting healthy tissue.See study design
What are the potential side effects?
Possible side effects include skin reactions from radiation, fatigue, nausea from chemotherapy drugs, low blood counts increasing infection risk, and potential liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is a specific type of anal cancer.
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My breast cancer is at a specific stage and size according to AJCC 8th edition.
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I can care for myself but may not be able to do active work.
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My blood counts and liver/kidney functions are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months following the completion of chemoradiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following the completion of chemoradiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to plan and deliver treatment fractions.
Secondary outcome measures
Acute Treatment Toxicity
Complete Clinical Response Rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Chemotherapy and Adaptive Radiation Treatment PlanningExperimental Treatment4 Interventions
Subjects will receive concurrent chemotherapy and radiation as part of their treatment for anal cancer. Subjects will receive standard of care 54 Gy of radiation, 5 days a week for 6 weeks. In addition, subjects will receive standard of care chemotherapy, with mitomycin C (10mg/meters squared IV on Day 1) and 5-Fluorouracil (1000mg/meters squared via IV on days 1-4 and 29-32) or capecitabine (825 mg/meters squared in two divided doses by mouth on days of radiotherapy).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Mitomycin-C
2011
Completed Phase 2
~240
5-Fluorouracil
2012
Completed Phase 3
~7800
Find a Location
Who is running the clinical trial?
Varian Medical SystemsIndustry Sponsor
58 Previous Clinical Trials
3,719 Total Patients Enrolled
VarianUNKNOWN
4 Previous Clinical Trials
406 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,426 Previous Clinical Trials
2,473,788 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had all of my tumor surgically removed.I am 18 years old or older.I've had radiation therapy to my pelvis that overlapped with previous treatments.I do not have an uncontrolled illness like severe HIV or heart disease.My cancer is a specific type of anal cancer.I have been cancer-free for over 2 years, except for non-melanoma skin cancer.I have had chemotherapy or radiation for anal cancer before.My breast cancer is at a specific stage and size according to AJCC 8th edition.I can care for myself but may not be able to do active work.My cancer has returned or spread to other parts of my body.My blood counts and liver/kidney functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy and Adaptive Radiation Treatment Planning
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.
How many enrollees are accepted for this research endeavor?
"Correct. According to clinicaltrials.gov, this medical trial was initially published on May 1st 2023 and is still actively recruiting patients at a single location with the aim of enrolling up to 20 people."
Answered by AI
Is this study currently recruiting participants?
"Clinicaltrials.gov confirms that this trial is actively recruiting participants, with the original posting dated May 1st 2023 and an updated version shared on April 27th 2023."
Answered by AI
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