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NCT01324141 · ClinicalTrials.gov registry record · Phase 1
Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01324141: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01324141 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01324141, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: \- 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. Objectives: \- 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 cancer. Eligibility: \- 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. Design: * 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 following schedule: * 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 radiation treatment * 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.
Interventions
- DRUG 5-Fluorouracil
- PROCEDURE Radiation Therapy
- DRUG Mitomycin-C
- DRUG Tempol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-03-18 |
| Est. Completion | 2015-04-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01324141
The ClinicalTrials.gov registry entry for NCT01324141 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which 5-Fluorouracil is the first listed.
NCT01324141 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01324141 about?
NCT01324141 is a clinical study titled "Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer". Background: \- 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 ...
What is the current status of trial NCT01324141?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-03-18. Estimated completion is 2015-04-15.
What interventions are being tested in trial NCT01324141?
The interventions under investigation include: 5-Fluorouracil (DRUG), Radiation Therapy (PROCEDURE), Mitomycin-C (DRUG), Tempol (DRUG).
Who is sponsoring clinical trial NCT01324141?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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