Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00002852|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: paclitaxel Drug: carboplatin Procedure: therapeutic conventional surgery||Phase 3|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG|
|Study Start Date :||October 1996|
|Primary Completion Date :||July 2004|
U.S. FDA Resources
Active Comparator: Arm I (surgery, observation)
Patients receive no further therapy.
Procedure: therapeutic conventional surgery
Experimental: Arm II (surgery, chemotherapy)
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.
Other Names:Drug: carboplatin
Other Names:Procedure: therapeutic conventional surgery
- Overall survival (OS) [ Time Frame: Up to 2.4 years ]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.
- Failure-free survival [ Time Frame: Time between randomization and disease relapse or death, assessed up to 2.4 years ]Failure-free survival curves will be calculated using the Kaplan-Meier life-table method.
- Toxicity as assessed by Common Toxicity Criteria version 2.0 [ Time Frame: Up to 1 year after completion of treatment ]
- Pattern of disease recurrence. [ Time Frame: Up to 2 years ]The frequency of local and distant relapse and the incidence of a second primary lung cancer will be tabulated by treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002852
|United States, Illinois|
|Cancer and Leukemia Group B|
|Chicago, Illinois, United States, 60606|
|Principal Investigator:||Gary Strauss||Cancer and Leukemia Group B|