- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00025090
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Sheffield, United Kingdom, S1O 2SJ
- Cancer Research Centre at Weston Park Hospital
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England
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Harrow, England, United Kingdom, HA1 3UJ
- Northwick Park Hospital
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Ipswich, England, United Kingdom, IP4 5PD
- Ipswich Hospital
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Leeds, England, United Kingdom, LS16 6QB
- Cookridge Hospital
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London, England, United Kingdom, EC1A 7BE
- Saint Bartholomew's Hospital
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London, England, United Kingdom, NW1 2ND
- Cancer Research UK and University College London Cancer Trials Centre
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Middlesbrough, England, United Kingdom, TS4 3BW
- James Cook University Hospital
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Northwood, England, United Kingdom, HA6 2RN
- Mount Vernon Cancer Centre at Mount Vernon Hospital
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Nottingham, England, United Kingdom, NG5 1PB
- Nottingham City Hospital
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Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden - Surrey
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Westcliff-On-Sea, England, United Kingdom, SS0 0RY
- Southend University Hospital NHS Foundation Trust
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Scotland
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Aberdeen, Scotland, United Kingdom, AB25 2ZN
- Aberdeen Royal Infirmary
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Wales
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Cardiff, Wales, United Kingdom, CF14 2TL
- Velindre Cancer Center at Velindre Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Recurrence-free survival
|
Complete response rate at 6 months
|
Acute toxicity as measured up to 4 weeks after chemoradiation
|
Secondary Outcome Measures
Outcome Measure |
---|
Colostomy rate
|
In field recurrence rate as measured by confirmed disease within radiation therapy field
|
Cause-specific and overall survival
|
Collaborators and Investigators
Investigators
- Study Chair: Roger D. James, MD, Maidstone Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Anus Diseases
- Anus Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Alkylating Agents
- Antibiotics, Antineoplastic
- Fluorouracil
- Mitomycins
- Mitomycin
Other Study ID Numbers
- CDR0000068911
- NCRI-ACT-II
- EU-20056
- UKCCCR-ACT-II
- ISRCTN26715889
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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