Combination Chemotherapy Followed by Surgery in Treating Patients With Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00003231|
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : May 15, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with docetaxel and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: docetaxel Procedure: surgical procedure Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Assess the efficacy and toxic effects of docetaxel plus cisplatin in patients with stage IIIA non-small cell lung cancer. II. Assess the clinical and pathological response rate to this therapy in this patient population. III. Compare the benefit of surgery in terms of overall survival of responding and nonresponding patients.
OUTLINE: Patients receive infusions of docetaxel over 1 hour on day 1, followed by infusions of cisplatin over 1 hour on days 1-2. Treatment is repeated for three 21 day courses. Patients undergo tumor resection and mediastinal lymph node dissection. Patients are to receive postoperative radiotherapy within 4 weeks of resection if the tumor reaches the resection margins and/or the first mediastinal lymph node levels are involved. Patients will be followed until death.
PROJECTED ACCRUAL: Approximately 5-40 patients will be accrued within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||Preoperative Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2)|
|Study Start Date :||April 1997|
|Actual Primary Completion Date :||September 2000|
|Actual Study Completion Date :||September 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003231
|Aarau, Switzerland, 5001|
|Office of Walter Weber-Stadelman|
|Basel, Switzerland, CH 4051|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Istituto Oncologico della Svizzera Italiana|
|Lugano, Switzerland, CH-6900|
|Solothurn, Switzerland, 4500|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Zurich, Switzerland, CH-8008|
|Study Chair:||Daniel C. Betticher, MD||University Hospital Inselspital, Berne|