Status:
UNKNOWN
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
Lead Sponsor:
Samsung Medical Center
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).
Eligibility Criteria
Inclusion
- Histologically confirmed nonsquamous NSCLC
- Stage IIIb, IV or recurrent NSCLC
- Age ≥ 18years
- ECOG performance status of 0 to 1
- Known TS immunohistochemical analysis data
- At least one measurable lesion by RECIST 1.1
- No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC
- Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
- At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
- Adequate renal function: estimated creatinine clearance ≥ 50mL/min
Exclusion
- Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
- Patients with post-obstructive pneumonia or uncontrolled serious infection
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01401192
Start Date
July 1 2011
Last Update
July 25 2011
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea