A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III
cisplatin
+ gemcitabine hydrochloride
+ radiation therapy
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Lung Diseases
Treatment Study
Summary
Study start date: February 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Compare survival, disease-free survival, local control, and pattern of recurrence in patients with unresectable stage I, II, or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin. Compare the acute and late toxic effects of these regimens in these patients. Determine the quality of life of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2. Treatment is repeated once 21 days later. Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 (day 57), 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy. Arm II: Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy. Treatment continues daily, 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy. Quality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35. Patients are followed at 3 weeks, 6-7 weeks, and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 418 patients (209 per arm) will be accrued for this study within 5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.158 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage I, II, III (T1-4, N0-3, M0) No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes Medically inoperable or unresectable No pleural or pericardial effusion (except with repeated negative cytology) PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 6.8 g/dL No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours Hepatic: Not specified Renal: Creatinine no greater than 1.25 times normal OR Creatinine clearance greater than 70 mL/min Cardiovascular: No evidence of heart failure No myocardial infarction within the past 6 months No superior vena cava syndrome Pulmonary: FEV1 at least 1 L No pre-existing fibrotic lung disease No postobstructive pneumonia preventing exact delineation of tumor volume Diffusion capacity at least 60% Other: No weight loss of more than 10% in the past 3 months No uncontrolled infection No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the chest Maximum length of the esophagus receiving 40 Gy no greater than 18 cm Maximum length of the esophagus receiving 66 Gy no greater than 12 cm Must limit the spinal cord dose to a maximum of 50 Gy Must be able to exclude 25% of the heart from the boost volume Surgery: Not specified Other: No other concurrent experimental medications
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 17 locations
Hopital de Jolimont
Haine-Saint-Paul, BelgiumCHR de Grenoble - La Tronche
Grenoble, FranceMutterhaus der Borromaerinnen
Trier, Germany