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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00002852

Collaborator

(none)

500

Enrollment

Location

Arms

Study Details

Study Description

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:

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.

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

Study Type:

Interventional

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 :

Oct 1, 1996

Actual Primary Completion Date :

Jul 1, 2004

Arms and Interventions

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

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

Primary Outcome Measures

Overall survival (OS) [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 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

Toxicity as assessed by Common Toxicity Criteria version 2.0 [Up to 1 year after completion of treatment]
Pattern of disease recurrence. [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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