Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer

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Brief Title

Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer

Official Title

Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study

Brief Summary

      RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use
      different ways to stop tumor cells from dividing so they stop growing or die. Combining
      radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether
      radiation therapy and mitomycin are more effective when combined with fluorouracil or with
      cisplatin in treating anal cancer .

      PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and
      mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and
      cisplatin in treating patients with locally advanced anal cancer.
    

Detailed Description

      OBJECTIVES:

      Phase II

        -  Primary

             -  Compare the early clinical response (tumor response at 8 weeks) of patients with
                locally advanced anal cancer treated with radiotherapy with mitomycin and cisplatin
                vs mitomycin and fluorouracil.

        -  Secondary

             -  Compare the feasibility of these regimens in these patients.

             -  Compare the acute toxicity of these regimens in these patients.

             -  Compare patient compliance to these regimens.

      Phase III

        -  Primary

             -  Compare the event-free survival of patients treated with these regimens.

        -  Secondary

             -  Compare colostomy-free, disease-free, and overall survival of patients treated with
                these regimens.

             -  Compare locoregional control in patients treated with these regimens.

             -  Compare the late toxicity of these regimens in these patients.

             -  Compare quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center, T stage (T2 vs T3 vs T4), and nodal status (N0 vs N+). Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo radiotherapy once daily 5 days a week on weeks 1-4, 7-8, and 3
           days of week 9 (total of 33 fractions). Patients concurrently receive fluorouracil IV
           continuously on days 1-26 and 43-59 and mitomycin IV over 15 minutes on days 1 and 43.

        -  Arm II: Patients receive radiotherapy and mitomycin as in arm I and cisplatin IV over 1
           hour on days 1, 8, 15, 22, 43, 50, and 57.

      In both arms, treatment continues in the absence of disease progression or unacceptable
      toxicity.

      Quality of life is assessed at baseline, at weeks 12 and 26, and then every 6 months for 2
      years.

      Patients are followed every 2 weeks for 8 weeks, at week 26, and then every 6 months
      thereafter.

      PROJECTED ACCRUAL: A total of 678 patients (80 [40 per treatment arm] for phase II and 598
      [299 per treatment arm] for phase III) will be accrued for this study within 2-5 years.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II)

Secondary Outcome

 Acute toxicity and compliance to treatment as measured by CTC v 2.0 at completion of study treatment (Phase II)

Condition

Anal Cancer

Intervention

cisplatin


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

88

Start Date

July 2003


Primary Completion Date

November 2007

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell anal carcinoma

               -  Keratinizing or non-keratinizing

               -  The following stages are eligible:

                    -  T2, N0, M0 with maximum tumor diameter at least 4 cm

                    -  T3-T4, N0, M0

                    -  Any T, N1-N3, M0

          -  Tumor located in the anal canal OR in the anal margin and infiltrating the anal canal

          -  No primary adenocarcinoma of the anus

          -  Measurable disease

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 75

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Granulocyte count greater than 2,000/mm^3

          -  Platelet count greater than 100,000/mm^3

        Hepatic

          -  Not specified

        Renal

          -  Creatinine less than 1.4 mg/dL

        Cardiovascular

          -  No grade I angina pectoris with clinical symptoms within the past 3 months

          -  No grade II-IV angina pectoris within the past 3 months

          -  No stage II or greater distal arteritis

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other prior malignancy except adequately treated basal cell skin cancer or
             carcinoma in situ of the cervix

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study compliance and follow-up

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No other concurrent radiotherapy

        Surgery

          -  No prior colostomy

        Other

          -  No prior treatment for anal cancer
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Jean-Francois Bosset, MD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT00068744

Organization ID

EORTC-22011-40014

Secondary IDs

EORTC-22011

Responsible Party

Sponsor

Study Sponsor

European Organisation for Research and Treatment of Cancer - EORTC


Study Sponsor

Jean-Francois Bosset, MD, Study Chair, Hopital Jean Minjoz


Verification Date

September 2012