Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy. Secondary Compare the quality of life of patients treated with these regimens. Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens. Compare resectability rates in patients treated with these regimens. Compare time to and site of relapse in patients treated with these regimens. Determine response in patients treated with preoperative chemotherapy. Determine the adverse effects of preoperative chemotherapy in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo surgical resection no more than 4 weeks after randomization. Arm II: Patients receive one of the following chemotherapy regimens immediately after randomization: Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1. Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1. Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8. Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1. Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1. Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy. Quality of life is assessed at 6 and 12 months and then annually thereafter. Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.

Official Title
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Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: cisplatin
* Drug: docetaxel
* Drug: gemcitabine hydrochloride
* Drug: ifosfamide
* Drug: mitomycin C
* Drug: paclitaxel
* Drug: vinblastine sulfate
* Drug: vinorelbine tartrate
* Procedure: conventional surgery
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer Resectable disease Previously untreated disease No evidence of distant metastases PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm^3 Neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Not specified Renal: Not specified Other: Considered fit for chemotherapy and surgical resection No other disease or prior malignancy that would preclude study treatment No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis) No concurrent immunotherapy Chemotherapy: Not specified Endocrine therapy: No concurrent hormonal agents, except corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent anticancer therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|
|Drug: docetaxel|nan|
|Drug: gemcitabine hydrochloride|nan|
|Drug: ifosfamide|nan|
|Drug: mitomycin C|nan|
|Drug: paclitaxel|nan|
|Drug: vinblastine sulfate|nan|
|Drug: vinorelbine tartrate|nan|
|Procedure: conventional surgery|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter |  |  | 
| Clinical and post-surgery pathological staging at pre-randomization |  |  | 
| Resectability rates |  |  | 
| Extent of surgery |  |  | 
| Time to and site of relapse |  |  | 
| Tumor response to chemotherapy |  |  | 
| Adverse effects of chemotherapy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage 0 non-small cell lung cancer