Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 18 and over | NCI | RTOG-9208 RTOG-92-08 |
Objectives
I. Assess the acute tolerance to fluorouracil/mitomycin plus irradiation with 59.4 Gy (increased radiation dose compared to RTOG-8704) in patients with carcinoma of the anal canal. II. Determine whether tolerance differs greatly in high-risk patients who are HIV-positive.
Entry Criteria
Disease Characteristics:
Histologically proven, previously untreated carcinoma of the anal canal of the following histologies: Squamous cell Basaloid Cloacogenic Stage T1-4, any N, M0 disease required No in situ carcinoma of the anal canal Primary lesion measurable and at least 2 cm at entry
Prior/Concurrent Therapy:
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for anal cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for anal cancer Surgery: No prior surgery (other than excisional biopsy) for anal cancer
Patient Characteristics:
Age: 18 and over Performance status: Karnofsky 60-100% Hematopoietic: WBC at least 3,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.3 mg/dl Renal: Creatinine no greater than 1.4 mg/dl Other: No second malignancy within 5 years except skin neoplasms No AIDS (HIV-seropositive patients eligible)
Expected Enrollment
18 patients will be treated.
Outline
Radiotherapy plus 2-Drug Combination Chemotherapy. Pelvic irradiation using supervoltage equipment with energies of at least 6 MeV (electron or photon beams may be used for boosts); plus Fluorouracil, 5-FU, NSC-19893; Mitomycin, MITO, NSC-26980.Published Results
Konski A, Garcia M Jr, John M, et al.: Evaluation of planned treatment breaks during radiation therapy for anal cancer: update of RTOG 92-08. Int J Radiat Oncol Biol Phys 72 (1): 114-8, 2008.[PUBMED Abstract]
Konski AA, Winter K, et al.: Evaluation of planned treatment breaks during radiation therapy for anal cancer: update of Radiation Therapy Oncology Group (RTOG) 92-08. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-297, 2007.
John M, Pajak T, Flam M, et al.: Dose acceleration in chemoradiation (CRX) for anal cancer: preliminary results of RTOG 92-08. Int J Radiat Oncol Biol Phys 32(suppl 1): A33, 157, 1995.
Trial Lead Organizations
Radiation Therapy Oncology Group
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| Marshall Flam, MD, FACP, Protocol chair | |
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Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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