CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 288 enrolled
Drug / intervention
cisplatin, dexamethasone,vitamin B12, folic acid +1 moredrug
Likely dose
cisplatin, dexamethasone,vitamin B12, folic acid 75mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01194453
NCT01194453Phase 2Completed
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A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study

Sun Yat-sen University·interventional·Posted Sep 3, 2010·Updated Jun 16, 2016

In Brief

A Phase 2 clinical trial evaluating cisplatin, dexamethasone,vitamin B12, folic acid and cisplatin, gemcitabine for Non-small Cell Lung Cancer and Efficacy. Completed, enrolled 288 participants across 1 site.

Detailed Summary

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer, Efficacy
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 3, 2010
Enrollment StartNov 1, 2009
Primary CompletionSep 1, 2010
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.8 years ago

Interventions

cisplatin, dexamethasone,vitamin B12, folic aciddrug

Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment

cisplatin, gemcitabinedrug

cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8