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Chemotherapy or Observation in Treating Patients With Stage I Non-Small Cell Lung Cancer - NCT00863512-54601(Clinical Trial 383800)



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City:  La Crosse
State:  
WI
Zip Code: 54601
Conditions: Lung Cancer
Purpose: 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 stage I non-small cell lung cancer.
Study summary: OBJECTIVES: Primary - To determine the potential survival benefit of adjuvant chemotherapy vs standard care (observation) in patients with stage I non-small cell lung cancer. - To determine the potential survival benefit of adjuvant chemotherapy vs standard of care (observation) in patients with a high-risk Lung Metagene Score (LMS). - To validate the survival difference between LMS-risk groups (high-risk vs low-risk) in patients receiving standard care (observation). Secondary - To evaluate the predictive value of the LMS on survival of these patients by testing the interaction of the treatment (chemotherapy vs observation) by risk group (high-risk vs low-risk). - To compare the LMS with best clinico-pathologic staging for cancer-free survival of these patients. - To evaluate survival differences in patients with a low-risk LMS who are receiving chemotherapy vs observation. - To evaluate survival differences between patients with high-risk vs low-risk LMS who receive chemotherapy. - To evaluate the accuracy of other genomic-based lung cancer prognostic models using data from the patients receiving observation after resection. - To characterize the rate of chemotherapy toxicity for the different chemotherapy treatment regimens. OUTLINE: This is a multicenter study. Patients are stratified according to risk group (high vs low) and pathologic stage (IA vs IB). Patients are randomized to 1 of 2 treatment arms within 12 weeks after surgery. All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection). - Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. - Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1. - Regimen 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60 minutes on day 1. - Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1. - Regimen 4: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 60 minutes on day 1. - Arm II: Patients receive standard care (observation). Tissue obtained at surgery is examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each patient and correlated with survival and response. After completion of study treatment, patients are followed every 6 months for 5 years and then once a year for 7 years.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Stage I disease - Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma) - Tumor measuring ≥ 2.0 cm and < 6.0 cm in diameter by CT scan - 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
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Data Source: ClinicalTrials.gov
Date Processed: July 21, 2010
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