Random Trial for Elderly Patients With NSCLC | NCT00265694

Studies
Random Trial for Elderly Patients With NSCLC

NCT00265694

Sponsor

Inje University

Status

Unknown status

Last Update Posted

Dec 15, 2005Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Non-Small Cell Lung Cancer

Interventions

vinorelbine, gemcitabine and carboplatin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 14, 2005

First Submission Date that Met QC Criteria

Dec 14, 2005

First Posted Date

Dec 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2005

Last Update Posted Date

Dec 15, 2005Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
vinorelbine, gemcitabine and carboplatin	Drug

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Young Jin Yuh, M.D.	Contact	82-2-950-1460		yjyuh@sanggyepaik.ac.kr

Overall Officials

Name	Affiliation	Role
Young Jin Yuh, M.D.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje University Sanggyepaik Hospital	Recruiting	Seoul		139-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077235	Vinorelbine
D000093542	Gemcitabine
D016190	Carboplatin

Ancestor Terms

ID	Term
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided