Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

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Brief Title

Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

Official Title

A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal

Brief Summary

      RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
      the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in
      chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth
      of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor
      cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving
      intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in
      treating patients with invasive anal cancer.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil,
           and mitomycin C decreases the combined rate of gastrointestinal and genitourinary
           adverse events (grade II or greater) by at least 15% in the first 90 days after the
           start of treatment in patients with primary invasive carcinoma of the anal canal
           compared to patients treated on the radiotherapy, fluorouracil, and mitomycin C arm on
           clinical trial RTOG 98-11.

      Secondary

        -  Determine the feasibility of performing IMRT in these patients in a cooperative group
           setting.

        -  Evaluate adverse events experienced by patients treated with this regimen and to
           decrease the grade 2 and higher and grade 3 and higher overall adverse event rates by
           15% or 20% as compared to the radiotherapy and mitomycin C arm of RTOG 98-11.

        -  Evaluate the total duration of radiotherapy.

        -  Evaluate the efficacy of this regimen, in terms of locoregional failure, disease-free
           survival, time to colostomy, colostomy-free survival, and overall survival of these
           patients.

        -  Determine clinical complete response at 8 weeks after completion of study treatment.

      OUTLINE: This is a multicenter study.

      Patients receive mitomycin C IV over 10-30 minutes on days 1 and 29 and fluorouracil IV
      continuously over 96 hours on days 1-4 and 29-32. Patients also undergo dose-painted
      intensity-modulated radiation therapy once daily, 5 days a week, for 5½ to 6 weeks beginning
      on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 1 year, every 6
      months for 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)

Secondary Outcome

 Number of Patients With Major Radiation Planning Deviations

Condition

Anal Cancer

Intervention

fluorouracil

Study Arms / Comparison Groups

 5-FU + Mitomycin + IMRT
Description:  5-FU + Mitomycin + IMRT

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

63

Start Date

December 2006

Completion Date

December 2016

Primary Completion Date

February 2009

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed carcinoma of the anal canal, including any of the following
             subtypes:

               -  Squamous cell

               -  Basaloid

               -  Cloacogenic

          -  Primary invasive disease

          -  T2-4, N0-3 disease

               -  Clinically positive small inguinal nodes (i.e., < 1 cm in size) must be confirmed
                  by biopsy (preferably fine-needle aspiration) within the past 6 weeks

               -  Biopsy is not required for enlarged inguinal, perirectal, or pelvic nodes on exam
                  or CT scan that are found to be ≥ 1.0 cm and are considered to be clinically
                  positive

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

          -  ALT and AST < 3 times upper limit of normal

          -  Absolute neutrophil count ≥ 1,800/mm³

          -  Serum creatinine ≤ 1.5 mg/dL

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin < 1.4 mg/dL

          -  WBC ≥ 3,000/mm³

          -  INR ≤ 1.5

          -  No known AIDS

               -  HIV-positive patients without AIDS are eligible

               -  HIV test required for patients with clinical suspicion of AIDS

          -  No other invasive malignancy within the past 3 years except for nonmelanomatous skin
             cancer

          -  No severe, active comorbidity, defined as any of the following:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the past 6 months

               -  Transmural myocardial infarction within the past 6 months

               -  Acute bacterial or fungal infection requiring IV antibiotics

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study treatment

               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

               -  Uncontrolled diabetes mellitus, uncompensated heart disease, and/or uncontrolled
                  high blood pressure, that in the opinion of the patient's treating physician,
                  requires an immediate change in management

                    -  Patients may be eligible if appropriate changes in management have resulted
                       in adequate control of the above mentioned conditions

               -  Other immunocompromised status (e.g., organ transplantation or chronic
                  glucocorticoid use)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior radiation therapy to the pelvis that would result in overlap of radiation
             therapy fields

          -  No prior systemic chemotherapy for cancer of the anus

          -  No prior surgery for cancer of the anus that removed all macroscopic anal cancer

          -  No concurrent sargramostim (GM-CSF)

          -  No concurrent amifostine
      

Gender

All

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Lisa A. Kachnic, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00423293

Organization ID

RTOG-0529

Secondary IDs

CDR0000524057

Responsible Party

Sponsor

Study Sponsor

Radiation Therapy Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Lisa A. Kachnic, MD, Study Chair, Boston Medical Center


Verification Date

February 2019