- Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin that
can lead to redness and tenderness, and in some cases can be so severe that it results in
blistering or peeling of the skin during treatment. These conditions cause discomfort and may
require breaks from radiation treatment. Researchers are interested in determining whether
MTS-01, a drug that protects cells and tissues from the effects of radiation, can be given
before radiation treatment to prevent these side effects and reduce the irritation of the
skin during chemotherapy and radiation for anal cancer.
- To determine the safety and effectiveness of topical MTS-01 given before radiation in the
groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal
- Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal
and are eligible to receive radiation and chemotherapy treatments.
- Participants will be screened with a physical examination, medical history, blood tests,
imaging studies and physical examination of the anal canal, and biopsies as needed to
evaluate eligibility for treatment.
- Participants will be scheduled for radiation and chemotherapy treatments on the
- Radiation given 5 days per week for 6 weeks, with topical MTS-01 treatment on the skin
in the groin areas and between the buttocks before each treatment
- Mitomycin C given intravenously on days 1 and 29 of treatment
- 5-Fluorouracil given intravenously over 4 days (first week and fifth week) during
- Participants will be monitored throughout the treatment for side effects, with
photographs of the treatment area and frequent blood tests.
- Following the end of radiation, participants will have followup visits for 1 year with
blood tests and imaging studies to evaluate the response to treatment.