A Phase 2 interventional study of cisplatin and docetaxel in Lung Cancer, sponsored by Swiss Group for Clinical Cancer Research. Completed at 9 sites in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Swiss Group for Clinical Cancer Research · Phase 2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Swiss Group for Clinical Cancer Research is the lead sponsor of 107 studies on the registry; none are open to participants now.
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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
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Swiss Group for Clinical Cancer Research