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


Phase 3
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival (OS)

Outcome Description:

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.

Outcome Time Frame:

Up to 2.4 years

Safety Issue:

No

Principal Investigator

Gary Strauss

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02967

NCT ID:

NCT00002852

Start Date:

October 1996

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606