Study on Shortening Radiation Treatment with Chemotherapy for High-Risk Anal Cancer
Sponsor: University of Vermont Medical Center
ClinicalTrials ID:NCT07775209
This clinical trial is testing a shorter radiation treatment combined with standard chemotherapy to see if it can effectively control high-risk anal cancer while reducing the treatment time and burden on patients.
Patient Parameters
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Program Overview
This study is exploring whether a shorter course of radiation therapy, given with standard chemotherapy drugs mitomycin C and capecitabine, can effectively treat high-risk anal squamous cell carcinoma without spreading. Normally, treatment takes about 5.5 to 6 weeks, which can be challenging for patients, especially those in rural areas. The new approach uses a 23-session radiation plan over about 4.5 weeks, aiming to maintain the same effectiveness as the longer treatment. The main goal is to see if this shorter treatment can achieve a good response in patients after 6 months while keeping side effects manageable.
Description
The usual treatment for high-risk anal cancer involves about 27 to 30 sessions of radiation over 5.5 to 6 weeks, along with chemotherapy. This can be difficult for patients, especially those living far from treatment centers. This study is testing a shorter treatment plan that uses 23 radiation sessions over about 4.5 weeks, combined with standard chemotherapy drugs mitomycin C and capecitabine. The study focuses on patients with larger tumors or cancer that has spread to nearby lymph nodes. The main goal is to see if this shorter treatment can achieve a complete response in patients after 6 months. Researchers will also look at survival rates, disease control, side effects, quality of life, and treatment burden. They will collect blood samples to study tumor DNA and may interview patients and caregivers about their treatment experience.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Diagnosed with non-metastatic anal squamous cell carcinoma that is either a T2 tumor 4 cm or larger, T3 or T4 disease, or has spread to lymph nodes
- Patients with HPV-related perianal cancer are eligible if the cancer reaches the anal verge
- Good overall health with a performance status score over 60
- Kidney function with creatinine clearance over 30 mL/min
- Suitable for chemotherapy with capecitabine and mitomycin C
- Able to understand and willing to sign informed consent
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and for 90 days after treatment
Exclusion Criteria
- Previous radiation therapy to the pelvic area
- Uncontrolled health issues that could make radiation or chemotherapy unsafe
- Other cancers that could affect the study's safety or effectiveness
- Currently receiving another experimental treatment for anal cancer
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Vermont Medical Center | 05401 | Burlington | Vermont |
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