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

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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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall survival (OS)

Secondary Outcome

 Toxicity as assessed by Common Toxicity Criteria version 2.0

Condition

Adenocarcinoma of the Lung

Intervention

paclitaxel

Study Arms / Comparison Groups

 Arm I (surgery, observation)
Description:  Patients receive no further therapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

500

Start Date

October 1996


Primary Completion Date

July 2004

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gary Strauss, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00002852

Organization ID

NCI-2012-02967

Secondary IDs

CALGB-9633

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Gary Strauss, Principal Investigator, Cancer and Leukemia Group B


Verification Date

July 2013