In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC. This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.
OUTLINE: This is a multi-center study. * Cisplatin 50 mg/m2 d1, 8, 29, 36 * Etoposide 50 mg/m2/day d1-5, 29-33 * Radiation 5940 cGy (180 cGy/day) Patients with CR, PR, SD Randomized to either:Docetaxel75 mg/m2 q3wk X 3 cycles or Observation Only Performance Status: ECOG 0 or 1 Life Expectancy: Not specified Hematopoietic: * ANC \> 1,500/mm3 * Platelet count \> 100,000/mm3 * Hemoglobin \> 8 g/dl. PRBC transfusions will be allowed to increase hemoglobin to \>8 g/dl Hepatic: * Serum bilirubin \< institutional upper limit of normal (ULN) * AST \< 2.5 X the upper limits of normal if alkaline phosphatase is \< ULN, or alkaline phosphatase may be up to 4 X ULN if AST are \< ULN Renal: * Serum creatinine of \< 2 mg/dl or calculated creatinine clearance \> 50 cc/min Cardiovascular: * No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication). Pulmonary: * Pre-registration FEV1 \> 1 liters by spirometry within 42 days prior to study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
243
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States
Community Regional Cancer Center
Indianapolis, Indiana, United States
Medical Consultants, P.C.
Muncie, Indiana, United States
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, United States
...and 5 more locations
Overall Survival
A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.
Time frame: Participants were measured from treatment initiation to death
Progression Free Survival
A comparison of progression free survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median PFS time and a log rank test were used to analyze the hypothesized improvement in progression free survival. Progression is defined by RECIST as a 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.
Time frame: Participants were monitored from treatment initiation until disease progression per RECIST or death
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