Non-Small Cell Lung CancerPhase 3NCT00265694
Random Trial for Elderly Patients With NSCLC
A Phase 3 study testing vinorelbine, gemcitabine and carboplatin in people with Non-Small Cell Lung Cancer, run by Inje University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- vinorelbine, gemcitabine and carboplatin
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inje University Sanggyepaik Hospital
Seoul, 139-707
Young Jin Yuh, M.D., 82-2-950-1460, yjyuh@sanggyepaik.ac.kr
Young Jin Yuh, M.D.
About this study
Official title: A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer
- 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- vinorelbine, gemcitabine and carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinorelbine, gemcitabine and carboplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Investigators
- Young Jin Yuh, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265694
- Sponsor's protocol ID
- INJE05-06
- Status last verified
- Jun 2005
- First submitted
- 14 Dec 2005
- Last updated
- 15 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00265694
- Acronym / sponsor ID
- INJE05-06
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- First posted
- 15 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vinorelbine, gemcitabine and carboplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Jin Yuh, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vinorelbine, gemcitabine and carboplatin in people with Non-Small Cell Lung Cancer, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Jin Yuh, M.D. (82-2-950-1460, yjyuh@sanggyepaik.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2005.