Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Docetaxel; Gemcitabine; Pemetrexed; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

• Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma)

• Primary tumor must be T1a, T1b, T2a, or T2b by AJCC 7.0

• No status

• Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan

• The mass must have a source document to verify tumor size in the greatest dimension, which includes a CT scan report, a clinic note from the enrolling physician, and/or a printed image with caliper measurements on the lung mass

• Node-negative disease

• Evidence of hilar or mediastinal node involvement by chest CT scan (> 1 cm diameter) must be assessed with mediastinoscopy, endo-esophageal ultrasound with biopsy, endo-bronchial ultrasound, bronchoscopy, or mediastinal nodal sampling before or at time of thoracotomy

• No locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Granulocytes ≥ 1,500/μL

• Platelet count ≥ 100,000/μL

• Bilirubin ≤ 1.5 mg/dL

• AST < 1.5 times upper limit of normal (ULN)

• Serum creatinine ≤ 1.5 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No history of prior or concurrent malignancy, except curatively treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

• More than 3 years since prior cytotoxic or anticancer treatment

• No concurrent treatment with hormones or other chemotherapeutic agents, except steroids given for adrenal failure, hormone administered for nondisease-related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic

• No concurrent thoracic radiotherapy