Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 28 for:    "Adenosquamous Lung Carcinoma" | "Antimitotic Agents"

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)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 3, 2013
Study Start Date  ICMJE October 1996
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
Official Title  ICMJE A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • 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  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm I (surgery, observation)
    Patients receive no further therapy.
    Intervention: 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.
    Interventions:
    • Drug: paclitaxel
    • Drug: carboplatin
    • Procedure: therapeutic conventional surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2013)
500
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00002852
Other Study ID Numbers  ICMJE NCI-2012-02967
CALGB-9633
CDR0000065095
CLB-C9633
U10CA031946 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary Strauss Cancer and Leukemia Group B
PRS Account National Cancer Institute (NCI)
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP