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

Squamous Cell Lung Cancer Clinical Trial

Official title:

A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002852
• Other study ID #: NCI-2012-02967
• Secondary ID: CALGB-9633CDR000
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 2, 2013
• Start date: October 1996

Study information

• Verified date: July 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Lung
• Adenocarcinoma, Bronchiolo-Alveolar
• Adenosquamous Cell Lung Cancer
• Bronchoalveolar Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Large Cell Lung Cancer
• Lung Neoplasms
• Squamous Cell Lung Cancer
• Stage IB Non-small Cell Lung Cancer

Intervention

Drug:
• paclitaxel
Given IV
• carboplatin
Given IV

Procedure:
• therapeutic conventional surgery
Undergo surgery

Locations

Country	Name	City	State
United States	Cancer and Leukemia Group B	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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.	Up to 2.4 years	No
Primary	Failure-free survival	Failure-free survival curves will be calculated using the Kaplan-Meier life-table method.	Time between randomization and disease relapse or death, assessed up to 2.4 years	No
Secondary	Toxicity as assessed by Common Toxicity Criteria version 2.0		Up to 1 year after completion of treatment	Yes
Secondary	Pattern of disease recurrence.	The frequency of local and distant relapse and the incidence of a second primary lung cancer will be tabulated by treatment.	Up to 2 years	No