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Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01324141
Recruitment Status : Terminated
First Posted : March 28, 2011
Last Update Posted : July 5, 2018
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:


- 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 cancer.


- 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 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.

Condition or disease Intervention/treatment Phase
Anal Cancer Drug: Tempol Drug: 5-Fluorouracil Drug: Mitomycin-C Procedure: Radiation Therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial Assessing the Feasibility of Delivering Topical MTS-01 to Reduce Dermatitis in Patients Receiving Intensity Modulated Radiation With Concurrent 5-Fluorouracil and Mitomycin-C for Stage I-III Carcinoma of the Anal Canal
Study Start Date : March 18, 2011
Actual Primary Completion Date : April 15, 2015
Actual Study Completion Date : April 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arm Intervention/treatment
Experimental: 1
Chemo + Radiation
Drug: Tempol
Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of RT.

Drug: 5-Fluorouracil
5-FU will be delivered as 1000mg/m2/day as 96 hour continuous infusion beginning on day 1 and 29.

Drug: Mitomycin-C
MMC will be delivered at a dose of 10mg/m2 on days 1 and 29

Procedure: Radiation Therapy
RT will be delivered to a total dose of 50-54 Gy based on tumor characteristics.

Primary Outcome Measures :
  1. To determine the safety and tolerability of topical MTS-01 on a daily basis prior to irradiation in the groin and gluteal cleft of patients receiving combined therapy with MMC, 5-FU, and RT for carcinoma of the anal canal. [ Time Frame: Completion of study ]

Secondary Outcome Measures :
  1. To describe the rates and severity of skin toxicity in patients treated with this regimen [ Time Frame: Completion of study ]
  2. To describe the need for toxicity related treatment breaks with this regimen [ Time Frame: Completion of study ]
  3. To describe the opiate requirements in patients treated with this regimen [ Time Frame: Completion of study ]
  4. To describe 12-month progression-free survival, disease-free survival, and overall survival in patients treated with concurrent chemotherapy, radiation therapy, MTS-01 [ Time Frame: Completion of study ]
  5. Evaluate the effects of antiretroviral therapy, 5-fluorouracil, mitomycin C, and radiation on low level persistent HIV viremia and HIV genetic diversity [ Time Frame: Completion of study ]
  6. To evaluate the feasibility of collecting HIV RNA and mononuclear cells from rectal associated lymphoid tissue for correlative studies [ Time Frame: Completion of study ]
  7. Collect and store anal cytology and core needle biopsies of tumor for future HPV and tumor based analyses [ Time Frame: Completion of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Histologically proven, invasive primary squamous, basaloid, or cloacogenic carcinoma of the anal canal, stage T1-4, N0-3
  • No previous therapy for anal cancer.
  • Age greater than or equal to 18 years
  • ECOG performance status less than or equal to 2
  • Adequate bone marrow, renal, and hepatic function defined as

    • Absolute neutrophil count greater than or equal to 1,000 cells/mm(3)
    • Platelet count greater than or equal to 100,000/mm(3)
    • Hemoglobin greater than or equal to 8mg/dL
    • Creatinine clearance > 60 mL/min using Cockroft-Gault formula
    • Bilirubin less than or equal to 1.5 times ULN unless, during screening, the patient is receiving protease inhibitor therapy (i.e. indinavir, ritonavir, nelfinavir, and atazanavir) known to be associated with increased bilirubin: in this case total bilirubin less than or equal to 7.5 mg/dl and the direct fraction is less than or equal to 0.7 mg/dl.
    • WBC greater than or equal to 3,000/microL
    • ALT/AST less than or equal to 3 times the upper limit of normal
    • International normalized ratio (INR) less than or equal to 1.5
  • Patients of childbearing potential must be willing to use a medically effective means of birth control for the duration of treatment and six weeks after treatment.
  • Patients must be willing and able to provide informed consent


  • Contraindications to radiotherapy such as a history of prior radiotherapy to the pelvis or a history of inflammatory bowel disease
  • Prior malignancy except:

    • non-melanoma skin cancer
    • controlled Kaposi s Sarcoma (no chemotherapy for KS for 3 months, and no expected need for chemotherapy for the 12-month period of the study)
    • other malignancies with disease free period of at least 3 years
  • Presence of metastatic disease (M1)
  • Co-morbidity that in the estimation of the principal investigator would make the patient unable to tolerate treatment
  • Pregnant or lactating females
  • HIV positive patients with CD4 < 100 cells/mL AND ECOG PS greater than 2.
  • Dermatitis in the anticipated radiation treatment portal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01324141

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)
Layout table for additonal information Identifier: NCT01324141    
Other Study ID Numbers: 110129
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: April 15, 2015
Keywords provided by National Institutes of Health Clinical Center (CC):
Anal Cancer
Additional relevant MeSH terms:
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Anus Neoplasms
Skin Diseases
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors