NCT00216125

Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Nasser Hanna, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin 50 mg/m2 day 1, 8, 29, 36
DRUG	Etoposide	Etoposide 50 mg/m2, days 1-5, 29-33
RADIATION	Radiation	Radiation 5940 cGy (180 cGy/day)
DRUG	Docetaxel	docetaxel 75mg/m2 q3wk x 3 cycles

Timeline

• Start date: 2002-02-01
• Primary completion: 2006-06-01
• Completion: 2008-03-01
• First posted: 2005-09-22
• Last updated: 2016-03-16
• Results posted: 2016-02-08

Locations

15 sites across 1 country: United States