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
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).
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.
- Histologically documented non-small cell carcinoma
- Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging
- 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
- 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