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.
Drug: mitomycin C
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer|
- Complete response rate at 6 months [ Designated as safety issue: No ]
- Acute toxicity as measured up to 4 weeks after chemoradiation [ Designated as safety issue: Yes ]
- Recurrence-free survival [ Designated as safety issue: No ]
- Colostomy rate [ Designated as safety issue: No ]
- In field recurrence rate as measured by confirmed disease within radiation therapy field [ Designated as safety issue: No ]
- Cause-specific and overall survival [ Designated as safety issue: No ]
|Study Start Date:||March 2001|
|Study Completion Date:||August 2007|
- 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.
|Northwick Park Hospital|
|Harrow, England, United Kingdom, HA1 3UJ|
|Ipswich, England, United Kingdom, IP4 5PD|
|Leeds, England, United Kingdom, LS16 6QB|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Cancer Research UK and University College London Cancer Trials Centre|
|London, England, United Kingdom, NW1 2ND|
|James Cook University Hospital|
|Middlesbrough, England, United Kingdom, TS4 3BW|
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Nottingham City Hospital|
|Nottingham, England, United Kingdom, NG5 1PB|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, United Kingdom, S1O 2SJ|
|Study Chair:||Roger D. James, MD||Maidstone Hospital|