Phase II Study of Neoadjuvant XELOX + Lapatinib in HER2(+) Gastric Cancer Patients With Liver Metastasis
- Sponsor
- Samsung Medical Center
- Study ID
- NCT02015169
- Phase
- PHASE2
- Status
- Completed
Conditions
- HER2-positive Gastric Cancer Patients With Liver Metastasis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lapatinib — DRUGlapatinib 1250mg qd daily up to 8 cycles (3 weeks \* 8 cycles = 24 weeks)
Study Details
We planned this study to investigate the efficacy and safety of XELOX (capecitabine and oxaliplatin) plus lapatinib treatment in HER2-positive gastric cancer patients with liver metastasis.
Key Dates
- Start date
- Jul 9, 2012
- Status verified
- Jan 2018
- Primary completion
- Jul 17, 2017
- Completion
- Nov 17, 2017
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: XELOX+lapatinibD1 Oxaliplatin130mg/m2 + D5W 500ml MIV over 2hrs D1-D14 Capecitabine 850mg/m2 p.o bid D1 \~ Lapatinib 1250 mg qd dailiy
Primary Outcome Measure
complete resection rate (R0 resection rate) (defined as no macroscopic or microscopic residual tumor). [ Time Frame: after surgery, up to 3weeks ]