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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess whether consolidation therapy with docetaxel as compared with observation following cisplatin/etoposide/radiotherapy improves overall survival for patients with unresectable stage III non-small cell lung cancer (NSCLC).
36 months
No
Nasser Hanna, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Institutional Review Board
HOG LUN01-24
NCT00216125
February 2002
March 2008
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Elkhart Clinic | Elkhart, Indiana 46515 |
Community Regional Cancer Center | Indianapolis, Indiana 46256 |
Quality Cancer Center (MCGOP) | Indianapolis, Indiana 46202 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Center for Cancer Care, Inc., P.C. | New Albany, Indiana 47150 |
AP&S Clinic | Terre Haute, Indiana 47804 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
US Oncology | Houston, Texas 77060 |