Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With or Without Consolidation Docetaxel in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN01-24
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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