Preoperative Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2)
18 Years
75 Years
Both
Lung Cancer
Trial Information
Preoperative Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2)
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Daniel C. Betticher, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Inselspital, Berne
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 16/96
NCT ID:
NCT00003231
Start Date:
April 1997
Completion Date:
September 2000
Related Keywords:
- Lung Cancer
- squamous cell lung cancer
- large cell lung cancer
- stage IIIA non-small cell lung cancer
- adenocarcinoma of the lung
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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