Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00002852|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
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|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|
|Actual Primary Completion Date :||July 2004|
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.
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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
U10CA031946 ( U.S. NIH Grant/Contract )
|First Posted:||January 27, 2003 Key Record Dates|
|Last Update Posted:||July 3, 2013|
|Last Verified:||July 2013|
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma of Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action