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
Recruitment status was Recruiting
Sponsor:
Inje University
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
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Purpose
- 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.
- The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.
- 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:
Drug Information available for:
Carboplatin
Vinorelbine
Gemcitabine
Gemcitabine hydrochloride
Vinorelbine tartrate
U.S. FDA Resources
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 May 22, 2013