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


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.

Full Title of Study: “Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

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.


  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: mitomycin C
  • Radiation: radiation therapy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial


  • 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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University College London (UCL) Cancer Institute
  • Overall Official(s)
    • Roger D. James, MD, Study Chair, Maidstone Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.