Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
Completed · Phase 3
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT00002852
- Run by
- National Cancer Institute (NCI)
- People needed
- 500
- Starts
- 1996-10-01
- Last updated by the study team
- 2013-07-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Cancer and Leukemia Group B — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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