Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer

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Brief Title

Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer

Official Title

Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer

Brief Summary

      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet
      known if fluorouracil plus radiation therapy is more effective with or without additional
      chemotherapy in treating anal cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus
      radiation therapy with or without additional chemotherapy in treating patients who have
      primary anal cancer.
    

Detailed Description

      OBJECTIVES:

        -  Compare the response rates in patients with primary epidermoid anal cancer treated with
           radiotherapy and fluorouracil with either mitomycin or cisplatin and with or without
           maintenance therapy.

        -  Compare local control and prevention or delay of disease dissemination in patients
           treated with these regimens.

      OUTLINE: This is randomized, open-label, multicenter study. Patients are randomized to one of
      four treatment arms.

      All patients undergo radiotherapy daily 5 days a week for 5.5 weeks. All patients also
      receive fluorouracil IV continuously over days 1-4 and 29-32.

        -  Arm I: Patients receive mitomycin IV on day 1.

        -  Arm II: Patients receive cisplatin IV on days 1 and 29.

        -  Arm III: Patients receive mitomycin as in arm I and maintenance therapy comprising
           fluorouracil IV continuously over days 1-4 and cisplatin IV on day 1 beginning 4-8 weeks
           after completion of primary therapy and repeating once 3 weeks later.

        -  Arm IV: Patients receive cisplatin as in arm II and maintenance therapy as in arm III.

      Patients are followed at 2 months, every 3 months for 2 years, every 6 months for 3 years,
      and then annually thereafter.

      Peer Reviewed and Funded or Endorsed by Cancer Research UK

      PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this
      study.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Complete response rate at 6 months

Secondary Outcome

 Colostomy rate

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

600

Start Date

March 2001

Completion Date

August 2007


Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary epidermoid anal cancer

               -  Squamous cell

               -  Basaloid

               -  Cloacogenic

          -  No adenocarcinoma, malignant melanoma, mucoepidermoid carcinoma, lymphoma, or
             microinvasive anal intraepithelial neoplasia (without evidence of invasive disease) in
             the anal canal or margin

          -  No metastatic disease

        PATIENT CHARACTERISTICS:

        Age:

          -  Not specified

        Performance status:

          -  0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC greater than 3,000/mm^3

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

          -  Hemoglobin greater than 10 g/dL

        Hepatic:

          -  Liver function tests no greater than 2 times normal

        Renal:

          -  Glomerular filtration rate at least 50 mL/min

        Cardiovascular:

          -  No cardiovascular disease

          -  No uncontrolled angina pectoris

          -  No heart failure

          -  No clinically significant cardiac arrhythmias

        Other:

          -  HIV negative

          -  No other significant concurrent illness

          -  Not predominately bed-bound or frail

          -  No severe sepsis

          -  No other prior or concurrent cancer or illness that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy to pelvis

        Surgery:

          -  Not specified

        Other:

          -  No prior therapy for anal cancer
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Roger D. James, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT00025090

Organization ID

CDR0000068911

Secondary IDs

NCRI-ACT-II


Study Sponsor

University College London (UCL) Cancer Institute


Study Sponsor

Roger D. James, MD, Study Chair, Maidstone Hospital


Verification Date

March 2007