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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B Southwest Oncology Group North Central Cancer Treatment Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003596 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus radiation therapy for anal cancer.
PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus radiation therapy to see how well it works compared to fluorouracil and cisplatin plus radiation therapy in treating patients with stage II or stage III anal cancer.
Condition | Intervention | Phase |
---|---|---|
Anal Cancer |
Drug: cisplatin Drug: fluorouracil Drug: mitomycin C Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin, and Radiotherapy in Carcinoma of the Anal Canal |
Estimated Enrollment: | 650 |
Study Start Date: | October 1998 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to gender, nodal status (positive vs negative), and primary tumor size (greater than 2 cm to 5 cm vs greater than 5 cm). Patients are randomized to 1 of 2 treatment arms.
In both arms, radiotherapy is administered daily, 5 days a week, for 5-6.5 weeks. Patients with T3, T4, or N+ lesions or T2 lesions with residual disease receive additional radiotherapy to a reduced field.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study within 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary squamous, basaloid, or cloacogenic carcinoma of the anal canal, other than carcinoma in situ
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Jaffer A. Ajani, MD | M.D. Anderson Cancer Center |
Study Chair: | Al B. Benson, MD, FACP | Robert H. Lurie Cancer Center |
Study Chair: | Joel E. Tepper, MD | UNC Lineberger Comprehensive Cancer Center |
Study Chair: | John S. MacDonald, MD | St. Vincent's Comprehensive Cancer Center - Manhattan |
Study Chair: | Michael G. Haddock, MD | Mayo Clinic |
Study ID Numbers: | CDR0000066667, RTOG-9811, CALGB-89808, ECOG-R9811, NCCTG-R9811, SWOG-R9811, GUMC-00125 |
Study First Received: | November 1, 1999 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00003596 |
Health Authority: | United States: Federal Government |
stage II anal cancer stage III anal cancer squamous cell carcinoma of the anus cloacogenic carcinoma of the anus basaloid carcinoma of the anus |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Squamous cell carcinoma Intestinal Diseases Mitomycins Rectal Diseases Intestinal Neoplasms Rectal neoplasm Carcinoma Epidermoid carcinoma |
Digestive System Diseases Cisplatin Fluorouracil Mitomycin Carcinoma, squamous cell Gastrointestinal Neoplasms Anal cancer Carcinoma, Squamous Cell Rectal cancer Anus Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Anus Diseases Alkylating Agents Nucleic Acid Synthesis Inhibitors |