Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC

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. Radiation therapy uses high energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer. Determine the rate of event-free survival at 1 year in patients treated with this regimen. Determine the operability and complete resection rate in patients treated with this regimen. Determine the postoperative 30-day mortality in patients treated with this regimen. Determine the response rate, failure pattern, and overall survival in patients treated with this regimen. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity. Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19. Patients undergo surgery within 3-4 weeks after completion of radiotherapy. Patients are followed at 1 month and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.

Official Title
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Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: Hyperfractionated
* Drug: Taxotere/Cisplatin
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed, operable stage IIIB non-small cell lung cancer T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax Squamous cell Adenosquamous cell Large cell Poorly differentiated No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan No malignant pleural or pericardial effusion No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST and/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 at least 60 mL/min Cardiovascular: No unstable cardiac disease requiring treatment No congestive heart failure No angina pectoris (even if medically controlled) No significant arrhythmia No myocardial infarction within the past 3 months Other: Not pregnant or nursing Fertile patients must use effective contraception No definite contraindications for the use of corticosteroids as premedication No preexisting grade 2 or greater peripheral neuropathy No active uncontrolled infection No uncontrolled diabetes mellitus No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent No other serious underlying medical condition that would preclude study participation No socioeconomic or geographical circumstances that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent) Radiotherapy: No prior radiotherapy to the chest Surgery: See Disease Characteristics Other: At least 30 days since prior treatment in a clinical trial No prior cytostatic therapy No other concurrent experimental drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Hyperfractionated|Hyperfractionated radiotherapy|
|Drug: Taxotere/Cisplatin|Taxotere/Cisplatin|
|Procedure: conventional surgery|conventional surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of event-free survival measured 1 year after registration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operability after chemotherapy |  |  | 
| Postoperative mortality 30 days after surgery |  |  | 
| Complete resection rate after surgery |  |  | 
| Toxicity |  |  | 
| Response rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, adenosquamous cell lung cancer