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Sponsored by: |
Swiss Group for Clinical Cancer Research |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003231 |
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 | Intervention | Phase |
Lung Cancer |
Drug: cisplatin Drug: docetaxel Procedure: radiation therapy Procedure: surgical procedure |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Cisplatin Docetaxel |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Preoperative Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2) |
Estimated Enrollment: | 40 |
Study Start Date: | April 1997 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage IIIA non-small cell lung cancer (NSCLC)(including squamous, adenocarcinoma, large cell, and poorly differentiated NSCLC) Nodal metastases of T1-3 N2 M0 No distant metastases
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance Status: WHO 0-2 Life Expectancy: Not specified Hematopoietic: Leucocytes greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin within normal limits AST or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine clearance greater than 60 mL/min No hypercalcemia Cardiovascular: No unstable cardiac disease No congestive heart failure No angina pectoris No significant arrhythmias No prior history of myocardial infarction within 3 months Pulmonary: Lung function test with a forced expiratory volume greater than 1.2 L/sec Neurologic: No dementia No peripheral neuropathy greater than grade 1 No psychosis No seizure disorders Other: No prior or concurrent malignancies, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No active uncontrolled infection or other serious medical conditions No diabetes mellitus treated with insulin No gastric ulcers
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior corticosteroids or other endocrine therapy No concurrent treatment with prednisone (except for prophylaxis, treatment of acute hypersensitivity, or chronic treatment initiated greater than 6 months prior to study entry) Radiotherapy: No prior radiotherapy Surgery: No prior surgery for malignancy Other: No concurrent treatment with other experimental drugs No involvement in clinical trials within 30 days of study No prior treatment with other cytostatic therapy
Switzerland | |||||
Burgerspital, Solothurn | |||||
Solothurn, Switzerland, 4500 | |||||
City Hospital Triemli | |||||
Zurich, Switzerland, 8063 | |||||
Hopital Cantonal Universitaire de Geneva | |||||
Geneva, Switzerland, CH-1211 | |||||
Inselspital, Bern | |||||
Bern, Switzerland, CH-3010 | |||||
University Hospital | |||||
Basel, Switzerland, CH-4031 | |||||
Kantonspital Aarau | |||||
Aarau, Switzerland, 5001 | |||||
Klinik Hirslanden | |||||
Zurich, Switzerland, CH-8008 | |||||
Office of Walter Weber-Stadelman | |||||
Basel, Switzerland, CH 4051 | |||||
Istituto Oncologico della Svizzera Italiana | |||||
Lugano, Switzerland, CH-6900 |
Swiss Group for Clinical Cancer Research |
Study Chair: | Daniel C. Betticher, MD | University Hospital Inselspital, Berne |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066100, SWS-SAKK-16/96, EU-97034 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003231 |
Health Authority: | United States: Federal Government |
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