Phase II Pilot Study of 5-FU/MITO plus Radiotherapy in Patients with Previously Untreated Carcinoma of the Anal Canal
Basic Trial Information
|Phase II||Treatment||Closed||18 and over||NCI||RTOG-9208|
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.
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
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
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)
18 patients will be treated.
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.
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.
Trial Contact Information
Trial Lead Organizations
Radiation Therapy Oncology Group
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.