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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002852
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
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.

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

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I (surgery, observation)
Patients receive no further therapy.
 Procedure: therapeutic conventional surgery
Undergo 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.
 Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin

Procedure: therapeutic conventional surgery
Undergo surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Toxicity as assessed by Common Toxicity Criteria version 2.0 [ Time Frame: Up to 1 year after completion of treatment ]
  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gary Strauss Cancer and Leukemia Group B
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002852    
Other Study ID Numbers: NCI-2012-02967
CALGB-9633
CDR0000065095
CLB-C9633
U10CA031946 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma of Lung
Adenocarcinoma, Bronchiolo-Alveolar
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action