Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed
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|ClinicalTrials.gov Identifier: NCT00002583|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : April 3, 2020
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is more effective than no further treatment for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine plus cisplatin with that of no further therapy in treating patients who have stage I or stage II non-small cell lung cancer that has been completely removed during surgery.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: vinorelbine ditartrate||Phase 3|
OBJECTIVES: I. Compare the duration of overall and disease-free survival in patients with completely resected non-small cell lung cancer (NSCLC) randomized to adjuvant chemotherapy with vinorelbine and cisplatin versus observation only. II. Confirm the prognostic significance of ras mutations when present in the primary tumor. III. Provide a comprehensive tumor bank linked to a clinical database for the further study of molecular markers in resected NSCLC. IV. Measure and compare the health-related quality of life of patients on both treatment arms. V. Evaluate any toxicity related to this treatment regimen.
OUTLINE: This is a randomized study. Patients are stratified according to participating institution, nodal status (N0 vs N1), and ras mutation status of primary tumor (absent vs present vs unknown). Patients are randomized to one of two treatment arms. Arm I: Patients are evaluated at 3 and 6 months after randomization. Arm II: Patients receive vinorelbine IV over 6-10 minutes weekly for 16 weeks. Patients also receive cisplatin IV on days 1 and 8 every 4 weeks for a total of 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at Canadian centers. Quality of life assessments are optional for ECOG and SWOG centers. Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 6.75 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||482 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Prospective Randomized Study of Adjuvant Chemotherapy With Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer With Companion Tumour Marker Evaluation|
|Actual Study Start Date :||July 7, 1994|
|Actual Primary Completion Date :||April 25, 2004|
|Actual Study Completion Date :||December 21, 2009|
No Intervention: Observation
Active Comparator: Chemotherapy
Cisplatin and Vinorelbine
50 mg/m2 IV
Drug: vinorelbine ditartrate
25 mg/m2 IV
- survival [ Time Frame: At time of death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002583
|Study Chair:||Timothy L. Winton, MD||University of Alberta|
|Study Chair:||Eric Vallieres, MD, FRCSC||University of Washington|
|Study Chair:||Russell F. DeVore, MD||Vanderbilt-Ingram Cancer Center|
|Study Chair:||James R. Rigas, MD||Norris Cotton Cancer Center|