Search / Trial NCT00002583

Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed

Launched by NCIC CLINICAL TRIALS GROUP · Apr 21, 2004

Trial Information

Current as of December 06, 2024

Completed

Keywords

Stage I Non Small Cell Lung Cancer Stage Ii Non Small Cell Lung Cancer

ClinConnect Summary

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 ...

Gender

ALL

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

Trial Officials

Timothy L. Winton, MD

Study Chair

University of Alberta

Eric Vallieres, MD, FRCSC

Study Chair

University of Washington

Russell F. DeVore, MD

Study Chair

Vanderbilt-Ingram Cancer Center

James R. Rigas, MD

Study Chair

Norris Cotton Cancer Center

About Ncic Clinical Trials Group

The NCIC Clinical Trials Group (NCIC CTG) is a leading Canadian organization dedicated to advancing cancer research through the design, conduct, and analysis of clinical trials. As part of the Canadian Cancer Society, NCIC CTG collaborates with various academic institutions, healthcare professionals, and industry partners to develop innovative treatment strategies and improve patient outcomes. The group focuses on a diverse range of cancer types and strives to enhance the understanding of cancer biology, treatment efficacy, and supportive care, thereby contributing to the global knowledge base in oncology. Through rigorous scientific methodologies and a commitment to ethical standards, NCIC CTG plays a pivotal role in shaping the future of cancer care.

Locations

Oklahoma City, Oklahoma, United States

Tucson, Arizona, United States

Buffalo, New York, United States

Vancouver, British Columbia, Canada

New York, New York, United States

Calgary, Alberta, Canada

Ann Arbor, Michigan, United States

Los Angeles, California, United States

Los Angeles, California, United States

Orange, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

Lexington, Kentucky, United States

Worcester, Massachusetts, United States

Detroit, Michigan, United States

Minneapolis, Minnesota, United States

Jackson, Mississippi, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Charleston, South Carolina, United States

Spartanburg, South Carolina, United States

Dallas, Texas, United States

Seattle, Washington, United States

Sacramento, California, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Providence, Rhode Island, United States

San Antonio, Texas, United States

Phoenix, Arizona, United States

Atlanta, Georgia, United States

Kansas City, Missouri, United States

Las Vegas, Nevada, United States

La Jolla, California, United States

San Francisco, California, United States

Wilmington, Delaware, United States

Miami Beach, Florida, United States

Baltimore, Maryland, United States

Columbia, Missouri, United States

Saint Louis, Missouri, United States

Lebanon, New Hampshire, United States

Manhasset, New York, United States

Syracuse, New York, United States

Winston Salem, North Carolina, United States

Memphis, Tennessee, United States

Richmond, Virginia, United States

New York, New York, United States

Maywood, Illinois, United States

New York, New York, United States

Morristown, New Jersey, United States

Edmonton, , Canada

Winnipeg, , Canada

Birmingham, Alabama, United States

Mobile, Alabama, United States

Long Beach, California, United States

Los Angeles, California, United States

Martinez, California, United States

Oakland, California, United States

Santa Rosa, California, United States

Travis Air Force Base, California, United States

Lexington, Kentucky, United States

New Orleans, Louisiana, United States

Jamaica Plain, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Saint Louis, Missouri, United States

Springfield, Missouri, United States

Billings, Montana, United States

Trenton, New Jersey, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Kettering, Ohio, United States

Portland, Oregon, United States

Greenville, South Carolina, United States

Galveston, Texas, United States

White River Junction, Vermont, United States

Seattle, Washington, United States

Victoria, British Columbia, Canada

Moncton, New Brunswick, Canada

Halifax, Nova Scotia, Canada

London, Ontario, Canada

Sudbury, Ontario, Canada

Thunder Bay, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Decatur, Illinois, United States

Albuquerque, New Mexico, United States

Temple, Texas, United States

Boston, Massachusetts, United States

Honolulu, Hawaii, United States

Livingston, New Jersey, United States

Manhasset, New York, United States

Cleveland, Ohio, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Little Rock, Arkansas, United States

Denver, Colorado, United States

Fort Gordon, Georgia, United States

Hines, Illinois, United States

Kansas City, Kansas, United States

Wichita, Kansas, United States

Shreveport, Louisiana, United States

Shreveport, Louisiana, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Southfield, Michigan, United States

Biloxi, Mississippi, United States

Jackson, Mississippi, United States

Keesler Air Force Base, Mississippi, United States

Kansas City, Missouri, United States

Saint Louis, Missouri, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Fort Sam Houston, Texas, United States

Lubbock, Texas, United States

San Antonio, Texas, United States

Temple, Texas, United States

Salt Lake City, Utah, United States

Salt Lake City, Utah, United States

Seattle, Washington, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Phoenix, Arizona, United States

New Orleans, Louisiana, United States

Grand Rapids, Michigan, United States

Portland, Oregon, United States

Syracuse, New York, United States

Memphis, Tennessee, United States

Richmond, Virginia, United States

Ste Foy, Quebec, Canada

Ottawa, Ontario, Canada

Chicago, Illinois, United States

Togus, Maine, United States

Minneapolis, Minnesota, United States

Columbia, Missouri, United States

Columbia, Missouri, United States

Omaha, Nebraska, United States

Flemington, New Jersey, United States

Hackensack, New Jersey, United States

Red Bank, New Jersey, United States

Buffalo, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

St. Catharines, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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