NCI HIGH PRIORITY CLINICAL TRIAL --- Phase III Study of CACP/VP-16 Combined with Standard Fractionation Thoracic Radiotherapy vs CACP/VP-16 Combined with Hyperfractionated Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
Basic Trial Information
|Phase III||Treatment||Completed||any age||NCI||EST-3588|
RTOG-8815, SWOG-8991, INT-0096
I. Compare, in a randomized Phase III setting, median and long-term (greater than 2-year) survival of patients with limited stage small cell lung cancer who are receiving cisplatin/etoposide induction chemotherapy combined with concurrent thoracic radiotherapy given on a standard once daily vs. a twice daily fractionation scheme. II. Compare these regimens with regard to failure rates within the thorax, within the radiation portal, and at distant sites. III. Compare the toxicities of standard fractionated vs. hyperfractionated thoracic radiotherapy given concurrently with chemotherapy. IV. Determine the clinical significance of variant morphologies of small cell carcinoma of the lung.
Limited stage small cell lung cancer (i.e., disease confined to 1 hemithorax that may include any mediastinal adenopathy and ipsilateral supraclavicular nodes but no contralateral hilar disease) Histologic or cytologic proof of disease required Thin needle aspiration acceptable as cytologic documentation, as is sputum cytology if biopsy is impossible provided there are at least 2 positive specimens Tumor must be encompassable within a single radiotherapy port No pericardial or pleural effusion Measurable or evaluable disease required
Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Age: Any age Performance status: ECOG 0-2 Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hepatic: Bilirubin no more than 1.5 mg/dl SGOT no more than 2 x normal Renal: Creatinine no more than 1.5 mg/dl Cardiovascular: No symptomatic heart disease, e.g., No angina No CHF No uncontrolled arrhythmia No MI within 6 months Pulmonary: FEV1 greater than 1 liter No uncontrolled bronchospasm in unaffected lung Other: No previous or concurrent other malignancy except: Curatively treated basal or squamous cell skin cancer Carcinoma in situ of the cervix (Exceptions may be discussed with the study or disease-oriented chairperson)
200 patients per arm will be entered. At an anticipated accrual rate of 160 patients/year, 2.5 years will be needed for accrual; an additional 2.5 years will be required for follow-up.
Randomized study. Patients achieving CR on either arm may be given prophylactic cranial irradiation (PCI) on Regimen A; PCI is optional. PCI may be given at the discretion of the patient's physician to patients achieving PR, but this practice is not encouraged. Arm I: 2-Drug Combination Chemotherapy plus Radiotherapy. Cisplatin, CACP, NSC-119875; Etoposide, VP-16, NSC-141540; plus thoracic irradiation using megavoltage photon equipment with peak energies of 6 MeV. Standard fractionation schedule. Arm II: 2-Drug Combination Chemotherapy plus Radiotherapy. CACP; VP-16; plus thoracic irradiation with equipment as in Arm I. Hyperfractionated schedule. Regimen A: Radiotherapy. PCI using any megavoltage photon equipment.
Yuen AR, Zou G, Turrisi AT, et al.: Similar outcome of elderly patients in intergroup trial 0096: Cisplatin, etoposide, and thoracic radiotherapy administered once or twice daily in limited stage small cell lung carcinoma. Cancer 89 (9): 1953-60, 2000.[PUBMED Abstract]
Turrisi AT 3rd, Kim K, Blum R, et al.: Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med 340 (4): 265-71, 1999.[PUBMED Abstract]
Yuen A, Zou G, Turrisi A, et al.: Similar outcome of elderly patients in Intergroup trial 0096: cisplatin (P), etoposide (E), and thoracic radiotherapy (TRT) administered once (QD) or twice daily (BID) in limited stage small cell lung cancer (SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1803, 467a, 1999.
Aisner SC, Turrisi A, Kim KM, et al.: Incidence and clinical significance of variant morphology (small cell/large cell subtype) in limited stage small cell lung cancer (SCLC). A prospective analysis of an intergroup ECOG, RTOG, and SWOG study. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1764, 458a, 1998.
Turrisi A, Kim K, Sause W, et al.: Observations after 5 year follow-up of intergroup trial 0096: 4 cycles of cisplatin (P) etoposide (E) and concurrent 45 GY thoracic radiotherapy by 25 GY PCI. Survival differences and patterns of failure . [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1757, 457a, 1998.
Johnson DH, Kim K, Sause W, et al.: Cisplatin (P) & etoposide (E) + thoracic radiotherapy (TRT) administered once or twice daily (BID) in limited stage (LS) small cell lung cancer (SCLC): final report of intergroup trial 0096. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A-1113, 374, 1996.
Johnson DH, Kim K, Turrisi AT, et al.: Cisplatin (P) & etoposide (E) + concurrent thoracic radiotherapy (TRT) administered once versus twice daily for limited-stage (LS) small cell lung cancer (SCLC): preliminary results of an intergroup trial. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1105, 333, 1994.
Johnson DH, Kim K, Turrisi AT, et al.: Cisplatin (P) and etoposide (E) + concurrent thoracic radiotherapy (TRT) administered once vs twice daily for limited-stage (LS) small cell lung cancer (SCLC): preliminary results of an intergroup trial. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1105, 1994.
Trial Contact Information
Trial Lead Organizations
Eastern Cooperative Oncology Group
Ph: 615-343-9454; 800-811-8480
Radiation Therapy Oncology Group
Southwest 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.