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Combination Chemotherapy Followed by Surgery in Treating Patients With Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00003231
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

November 1, 1999
June 3, 2004
May 15, 2012
April 1997
September 2000   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003231 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy Followed by Surgery in Treating Patients With Non-small Cell Lung Cancer
Preoperative Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2)

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.

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.

Phase 2
Primary Purpose: Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: docetaxel
  • Procedure: surgical procedure
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2000
September 2000   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
SAKK 16/96
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Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
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Study Chair: Daniel C. Betticher, MD University Hospital Inselspital, Berne
Swiss Group for Clinical Cancer Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP