Phase III Randomized Study of Radiotherapy and Fluorouracil With Either Mitomycin or Cisplatin and With or Without Maintenance Therapy in Patients With Primary Epidermoid Anal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

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Alternate Title

Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedNot specifiedOtherNCRI-ACT-II
EU-20056, UKCCCR-ACT-II, ISRCTN26715889, NCT00025090


  1. 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.
  2. Compare local control and prevention or delay of disease dissemination in patients treated with these regimens.

Entry 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

Prior/Concurrent Therapy:

    Biologic therapy:

  • Not specified


  • Not specified

    Endocrine therapy:

  • Not specified


  • No prior radiotherapy to pelvis


  • Not specified


  • No prior therapy for anal cancer

Patient Characteristics:


  • Not specified

    Performance status:

  • 0-2

    Life expectancy:

  • Not specified


  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3
  • 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

Expected Enrollment


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


Primary Outcome(s)

Complete response rate at 6 months
Acute toxicity as measured up to 4 weeks after chemoradiation
Recurrence-free survival

Secondary Outcome(s)

Colostomy rate
In field recurrence rate as measured by confirmed disease within radiation therapy field
Cause-specific and overall survival


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

Trial Contact Information

Trial Lead Organizations

UCL Cancer Institute

Roger James, MD, Protocol chair
Ph: 44-1622-225-135

Registry Information

Official TitleSecond UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients with Anal Cancer
Trial Start Date2001-03-26
Registered in ClinicalTrials.govNCT00025090
Date Submitted to PDQ2001-07-17
Information Last Verified2013-10-22

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.