Random Trial for Elderly Patients With NSCLC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Inje University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT00265694
First received: December 14, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose
  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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: vinorelbine, gemcitabine and carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 NLM:


Further study details as provided by Inje University:

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265694

Contacts
Contact: Young Jin Yuh, M.D. 82-2-950-1460 yjyuh@sanggyepaik.ac.kr

Locations
Korea, Republic of
Inje University Sanggyepaik Hospital Recruiting
Seoul, Korea, Republic of, 139-707
Contact: Young Jin Yuh, M.D.    82-2-950-1460    yjyuh@sanggyepaik.ac.kr   
Principal Investigator: Young Jin Yuh, M.D.         
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Young Jin Yuh, M.D.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00265694     History of Changes
Other Study ID Numbers: INJE05-06
Study First Received: December 14, 2005
Last Updated: December 14, 2005
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014