Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as high risk based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer). SECONDARY OBJECTIVES: I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy. II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the pattern of disease recurrence. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms. Arm I:Patients receive no further therapy. Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses. Patients are followed every 4 months for 2 years and then every 6 months thereafter.

Official Title
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A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG

Conditions
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Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: paclitaxel
* Drug: carboplatin
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically documented non-small cell carcinoma Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy) Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection No prior chemotherapy or radiation for non-small cell lung cancer Performance status of 0 or 1 Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years Granulocytes >= 1,800/ul Platelets >= 100,000/ul Bilirubin < 1.5 mg/dl SGOT (AST) < 2.0 x ULN

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (surgery, observation)<br>Patients receive no further therapy. | Procedure: therapeutic conventional surgery<br>* Undergo surgery<br>|
| Experimental: Arm II (surgery, chemotherapy)<br>Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses. | Drug: paclitaxel<br>* Given IV<br>* Other names: Taxol;Drug: carboplatin<br>* Given IV<br>* Other names: Paraplatin;Procedure: therapeutic conventional surgery<br>* Undergo surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS curves will be calculated using the Kaplan-Meier life-table method. Comparison of the survival curve for the two treatment regimens will be performed using the log-rank test for censored data. | Up to 2.4 years | 
| Failure-free survival | Failure-free survival curves will be calculated using the Kaplan-Meier life-table method. | Time between randomization and disease relapse or death, assessed up to 2.4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as assessed by Common Toxicity Criteria version 2.0 |  | Up to 1 year after completion of treatment | 
| Pattern of disease recurrence. | The frequency of local and distant relapse and the incidence of a second primary lung cancer will be tabulated by treatment. | Up to 2 years |