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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002583
• Date of registration: 01/11/1999
• Primary sponsor: NCIC Clinical Trials Group
• Public title: Vinorelbine Plus Cisplatin or No Further Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Surgically Removed
• Scientific 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
• Date of first enrolment: July 1994
• Target sample size: 482
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002583
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: James R. Rigas, MD
• Affiliation: Norris Cotton Cancer Center

• Name: Timothy L. Winton, MD
• Affiliation: University of Alberta

• Name: Eric Vallieres, MD, FRCSC
• Affiliation: University of Washington

• Name: Russell F. DeVore, MD
• Affiliation: Vanderbilt-Ingram Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Drug: cisplatin

Drug: vinorelbine ditartrate

Primary Outcome(s)

survival [Time Frame: At time of death]

Secondary ID(s)

BR10

CAN-NCIC-BR10

CDR0000063698

CLB-9795

E-JBR10

GW-565/040

NCI-V94-0492

SWOG-JBR10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Southwest Oncology Group