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Phase III Double-Blind Randomized Study of Low-Dose 13-CRA on Prevention of Second Primaries in Patients with Totally Resected Stage I/II Squamous Cell Carcinoma of the Head and Neck (Summary Last Modified 10/2000)
Alternate Title Isotretinoin Compared With Placebo in Preventing Second Primary Cancers in Patients Treated for Stage I or Stage II Head and Neck Cancer
Objectives I. Determine, in a phase III setting, the efficacy of isotretinoin (13-CRA) in preventing dysplastic changes and second malignancies in patients with squamous cell carcinoma of the head and neck region who have a high probability of cure from their primary cancer. II. Compare the time to diagnosis of a second primary and survival between patients treated with 13-CRA vs. placebo. III. Determine the cost-benefit ratio for 13-CRA by assessing the toxic effects experienced in patients treated with 13-CRA vs. those treated with placebo. Entry Criteria Disease Characteristics: Histologically confirmed squamous cell carcinoma of the head and neck rendered disease-free following primary surgery and/or radiotherapy The following AJCC sites and stages are eligible: Oral cavity, oropharynx, and larynx: T1-2, N0, M0 Hypopharynx: T1, N0, M0 Wide surgical excision with negative margins required Radical or modified radical neck dissection or primary radiotherapy required of some lesions (see protocol for details) Chest and cervical spine x-rays required within 30 days following primary therapy Prior/Concurrent Therapy: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: Radiotherapy completed within 2 years prior to randomization External-beam radiotherapy or brachytherapy allowed Surgery: Surgical resection completed within 2 years prior to randomization Patient Characteristics: Age: Over 18 Performance status: ECOG 0 or 1 Hematopoietic: (within 2 weeks prior to randomization) WBC at least 3,500 Platelets at least 125,000 Hepatic: (within 2 weeks prior to randomization) Bilirubin less than 2.0 mg/dL AST less than 2 times normal Alkaline phosphatase less than 2 times normal Fasting triglycerides less than 210 mg/dL Fasting cholesterol less than 350 mg/dL No systemic therapy for hyperlipidemia Renal: (within 2 weeks prior to randomization) Creatinine less than 2.5 mg/dL Cardiovascular: No severe (NYHA class III/IV) or symptomatic CAD No history of coronary artery bypass surgery Other: No fertile women No prior, synchronous, or concurrent malignancy except basal cell skin cancer Expected Enrollment Between 75 and 200 patients will be entered annually. Accrual will be stopped in the third, fourth, or fifth year if efficacy is highly significant (0.5% level). Outline Randomized, double-blind study. Arm I: Chemoprevention. Isotretinoin, 13-CRA, NSC-329481. Arm II: Control. Placebo, PLCB. Trial Lead Organizations Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Mayo Clinic Cancer Center
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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