Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer
N/A
N/A
Both
Anal Cancer
Trial Information
Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response rate at 6 months
Safety Issue:
No
Principal Investigator
Roger D. James, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Maidstone Hospital
Authority:
Unspecified
Study ID:
CDR0000068911
NCT ID:
NCT00025090
Start Date:
March 2001
Completion Date:
Related Keywords:
- Anal Cancer
- stage I anal cancer
- stage II anal cancer
- stage IIIA anal cancer
- stage IIIB anal cancer
- squamous cell carcinoma of the anus
- cloacogenic carcinoma of the anus
- basaloid carcinoma of the anus
- Anus Neoplasms
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