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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carboplatin; Paclitaxel

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