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
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: November 1, 1999
• First Posted Date: January 27, 2003
• Last Update Posted Date: July 3, 2013
• Study Start Date: October 1996
• Actual Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• 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

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 16, 2013): 500
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Canada, Puerto Rico

Administrative Information

• NCT Number: NCT00002852
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: National Cancer Institute (NCI)
• Original Responsible Party: Not Provided
• Current Study Sponsor: National Cancer Institute (NCI)
• Original Study Sponsor: Cancer and Leukemia Group B
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gary Strauss; Cancer and Leukemia Group B

• PRS Account: National Cancer Institute (NCI)
• Verification Date: July 2013