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Vinorelbine Plus Cisplatin or No Further Therapy in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed

This study is ongoing, but not recruiting participants.
Study NCT00002583.   Last updated on November 22, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Vinorelbine Plus Cisplatin or No Further Therapy in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed
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
Brief Summary

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.

Detailed Description

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 Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Lung Cancer
Intervention  Drug: cisplatin
Drug: vinorelbine ditartrate
MEDLINE PMIDs 18809617,   17141357,   17442999,   17289895,   15713522,   15972865,   18165640,   17410008,   17538170,   16462183,   16870041,   16236970
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  450
Start Date  July 1994
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS: Histologically confirmed primary non-small cell lung cancer that is completely resected No mixed small and non-small cell histologies Pathologic T2 N0 or T1-2 N1 T1 N1 and T2 N1 only for CALGB institutions Removal of all gross disease with negative resection margins by lobectomy, sleeve resection, bilobectomy, or pneumonectomy (based on intraoperative findings) No segmentectomy or wedge resection Complete mediastinal lymph node resection or sampling required at primary tumor resection, with minimum levels of nodal sampling as follows: Primary in right upper lobe - levels 4, 7, 10 Primary in right middle lobe - levels 4, 7, 10 Primary in right lower lobe - levels 4, 7, 9, 10 Primary in left upper lobe - levels 5, 6, 7, 10 Primary in left lower lobe - levels 7, 9, 10 If complete mediastinal lymph node resection has not been undertaken, any mediastinal lymph node which measured 1.5 cm or more on presurgical CT scan must have been biopsied and found to be free of metastatic involvement Disease at nodal station 10 (tracheobronchial angle) is considered N2 disease for this trial and is not eligible No more than one discrete primary tumor No bronchoalveolar carcinoma with lobar or multilobar involvement Discrete solitary radiological mass or nodule eligible Snap frozen fresh primary tumor tissue must be submitted to Lung Cancer Tumor Bank within 14 days after surgery by selected Canadian centers Others to submit representative paraffin block within 2 months of surgery

PATIENT CHARACTERISTICS: Age: 18 and over (lower age limit determined by individual center) Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin no greater than 1.25 times normal AST/ALT no greater than 1.25 times normal Alkaline phosphatase no greater than 1.25 times normal Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No history of congestive heart failure or other cardiac abnormality that may preclude hydration necessary for cisplatin administration Other: No active pathologic condition that would preclude study No active uncontrolled infection No history of psychiatric or neurologic disorder that would preclude study No prior breast cancer, melanoma, or hypernephroma No other malignancy within the past 5 years except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Ability to tolerate treatment (based on consultation between the thoracic surgeon and a medical oncologist or hematologist) and available for follow-up

PRIOR CONCURRENT THERAPY: Complete resection required Randomization between 28 and 40 days after surgery required

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00002583
Organization ID CDR0000063698
Secondary IDs †† CAN-NCIC-BR10, CLB-9795, E-JBR10, SWOG-JBR10, GW-565/040, NCI-V94-0492
Study Sponsor  National Cancer Institute of Canada
Collaborators †† National Cancer Institute (NCI)
Southwest Oncology Group
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Investigators 
Study Chair:     Timothy L. Winton, MD     University of Alberta Hospital    
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    
Information Provided By National Cancer Institute (NCI)
Verification Date November 2008
First Received Date  November 1, 1999
Last Updated Date November 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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