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Phase III Randomized Study of Radiotherapy with vs without CTX/MTX/CCNU for Limited Stage and of CTX vs CTX/MTX/CCNU for Extensive Stage Small Cell Lung Cancer (Summary Last Modified 10/94)
Basic Trial Information
Objectives I. Determine quality of life, time to disease progression, and survival in patients with limited stage small cell lung cancer treated with radiotherapy alone vs. radiotherapy followed by cyclophosphamide/methotrexate/lomustine (CTX/MTX/CCNU). II. Determine quality of life, time to disease progression, and survival in patients with extensive stage small cell lung cancer treated with single-agent CTX (1.0 g/sqm q 3 weeks) vs. CTX/MTX/CCNU. Entry Criteria Disease Characteristics: Histologically or cytologically proven small cell lung carcinoma confirmed by one of the following: Bronchial biopsy Mediastinal or other lymph node biopsy Pleural biopsy (pleural effusions not acceptable) Lung biopsy (by needle, trephine, or open surgery) Sputum cytology (bronchial brushings not acceptable) Histologic review at Brompton Hospital, London, required All small cell types (WHO classification) eligible, including: Fusiform Polygonal Lymphocyte-like Small anaplastic Limited and extensive stage disease eligible Limited stage defined by clinical and radiologic evidence as: Disease confined to the mediastinum and soft tissue of the ipsilateral thorax, including ipsilateral and contralateral scalene and ipsilateral and contralateral lower cervical nodes Small malignant or benign pleural effusions occupying no more than one-third of the ipsilateral hemithorax Disease associated with superior vena cava obstruction with no other signs of spread Disease encompassable within the proposed radiotherapy field Extensive disease defined by clinical and radiologic exam as: Disease that has spread beyond the mediastinum and ipsilateral hemithorax, including pleural effusion occupying more than one-third of the hemithorax The following are not by themselves indicators of extensive disease: Functional endocrine or neurologic syndrome Bone marrow examination or isotopic scan Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No surgery except thoracotomy (with or without biopsy) Patient Characteristics: Age: 70 and under Performance status: Not specified Life expectancy: Survival time not compromised by advanced disease Hematopoietic: No abnormalities of the blood Hepatic: Not specified Renal: BUN no greater than 60 mg/dl Other: No serious condition that would preclude protocol therapy No coexisting disease that would interfere with disease assessment No other major or advanced disease No pregnant women Expected Enrollment As of April 1977, 330 patients were registered and 253 were randomized. Outline Randomized study. Patients with limited stage disease are randomized to Arms I and II, while those with extensive stage disease are randomized to Arms III and IV. The following acronyms are used: CCNU Lomustine, NSC-79037 CTX Cyclophosphamide, NSC-26271 MTX Methotrexate, NSC-740 Arm I: Radiotherapy. Involved-field irradiation using megavoltage x-ray or Co60 gamma ray equipment. Arm II: Radiotherapy followed by 3-Drug Combination Chemotherapy. Radiotherapy as in Arm I; followed by CTX; MTX; CCNU. Arm III: Single-Agent Chemotherapy. CTX. Arm IV: 3-Drug Combination Chemotherapy. CTX; MTX; CCNU.Published Results Radiotherapy alone or with chemotherapy in the treatment of small-cell carcinoma of the lung: the results at 36 months. 2nd report to the Medical Research Council on the 2nd small-cell study. Br J Cancer 44 (5): 611-7, 1981.[PUBMED Abstract] Radiotherapy alone or with chemotherapy in the treatment of small-cell carcinoma of the lung. Medical Research Council Lung Cancer Working Party. Br J Cancer 40 (1): 1-10, 1979.[PUBMED Abstract] Trial Lead Organizations Medical Research Council Clinical Trials Unit
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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