Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00863512|
Recruitment Status : Terminated
First Posted : March 18, 2009
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: pemetrexed disodium Drug: vinorelbine tartrate Procedure: standard follow-up care||Phase 3|
- To determine the potential overall survival benefit of adjuvant chemotherapy in patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy compared to those randomized to the present standard of care (observation).
- To collect and process high-quality fresh frozen lung cancer tumor tissue for gene expression array generation from multiple institutions.
- To evaluate selected genomic-based lung cancer prognostic models using data from the patients randomized to observation after resection.
- To characterize the rate of chemotherapy toxicity for the different chemotherapy treatment regimens.
- To assess quality of life (QOL) in early stage patients periodically after resection for NSCLC.
- To examine the impact of chemotherapy on QOL for patients receiving chemotherapy, as compared to patients in the observation arm.
OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (I vs II) and ECOG performance status (0 vs 1). 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data|
|Study Start Date :||March 2009|
|Primary Completion Date :||November 2011|
|Study Completion Date :||November 2012|
Experimental: Arm I
Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Given IVDrug: docetaxel
Given IVDrug: gemcitabine hydrochloride
Given IVDrug: pemetrexed disodium
Given IVDrug: vinorelbine tartrate
Experimental: Arm II
Patients receive standard care (observation).
Procedure: standard follow-up care
- Overall Survival [ Time Frame: Up to 12 years ]Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863512
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|Study Chair:||David H. Harpole, MD||Duke Cancer Institute|