Clinical trial NCT00863512
Conditions: Lung Cancer
Keywords: stage IA non-small cell lung cancer stage IB non-small cell lung cancer stage IIA non-small cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer large cell lung cancer squamous cell lung cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2009-03-01; Completion date: 2012-11-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Arms: arm 1: 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. arm 2: Patients receive standard care (observation).
Interventions: intervention 1: cisplatin intervention 2: docetaxel intervention 3: gemcitabine hydrochloride intervention 4: pemetrexed disodium intervention 5: vinorelbine tartrate intervention 6: standard follow-up care
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV intervention 6: Standard care

Protocol documents: