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


        -  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 Phase

Phase 3

Study Type


Primary Outcome

Complete response rate at 6 months

Secondary Outcome

 Colostomy rate


Anal Cancer




* 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


Estimated Enrollment


Start Date

March 2001

Completion Date

August 2007

Eligibility Criteria


          -  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



          -  Not specified

        Performance status:

          -  0-2

        Life expectancy:

          -  Not specified


          -  WBC greater than 3,000/mm^3

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

          -  Hemoglobin greater than 10 g/dL


          -  Liver function tests no greater than 2 times normal


          -  Glomerular filtration rate at least 50 mL/min


          -  No cardiovascular disease

          -  No uncontrolled angina pectoris

          -  No heart failure

          -  No clinically significant cardiac arrhythmias


          -  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


        Biologic therapy:

          -  Not specified


          -  Not specified

        Endocrine therapy:

          -  Not specified


          -  No prior radiotherapy to pelvis


          -  Not specified


          -  No prior therapy for anal cancer




N/A - N/A

Accepts Healthy Volunteers



Roger D. James, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations



Organization ID


Secondary IDs


Study Sponsor

University College London (UCL) Cancer Institute

Study Sponsor

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

Verification Date

March 2007