Random Trial for Elderly Patients With NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265694
Recruitment Status : Unknown
Verified June 2005 by Inje University.
Recruitment status was:  Recruiting
First Posted : December 15, 2005
Last Update Posted : December 15, 2005
Information provided by:
Inje University

Brief Summary:
  1. Recently a radomized trial of vinorelbine versus best supportive care in patients at 70 years of age or older demonstrated a definite improvement in overall survival rate and quality of life with chemotherapy.
  2. The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.
  3. Gemcitabine and carboplatin have favorable toxicity profile.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: vinorelbine, gemcitabine and carboplatin Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with pathologically confirmed, advanced(clinical stage IIIB or IV) NSCLC
  • No previous chemotherapy history
  • Age ≥ 65 years
  • ECOG performance status ≤ 2
  • Adequate marrow function (ANC ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver function (total bilirubin < 2.0 mg/dL, AST/ALT levels < 3 × the upper limit of normal, serum creatinine < 2.0 mg/dL)
  • Patients with informed written consent

Exclusion Criteria:

  • Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00265694

Contact: Young Jin Yuh, M.D. 82-2-950-1460

Korea, Republic of
Inje University Sanggyepaik Hospital Recruiting
Seoul, Korea, Republic of, 139-707
Contact: Young Jin Yuh, M.D.    82-2-950-1460   
Principal Investigator: Young Jin Yuh, M.D.         
Sponsors and Collaborators
Inje University
Principal Investigator: Young Jin Yuh, M.D. Identifier: NCT00265694     History of Changes
Other Study ID Numbers: INJE05-06
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: December 15, 2005
Last Verified: June 2005

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic