Sorafenib Trial in Advanced and/or Recurrent Gastric Adenocarcinoma: Treatment Evaluation: STARGATE
NCT01187212 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195
Last updated 2020-01-07
Summary
This study investigates the efficacy and safety profiles of sorafenib in combination of capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced gastric cancer.
Conditions
- Malignant Neoplasm of Stomach
- Effects of Chemotherapy
Interventions
- DRUG
-
Capecitabine/Cisplatin + Sorafenib
Capecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing
- DRUG
-
Capecitabine/Cisplatin
Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day 1
Sponsors & Collaborators
- collaborator INDUSTRY
-
Asan Medical Center
lead OTHER
Principal Investigators
-
Kang Yoon-Koo, MD, PhD · Asan Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2013-11-30
- Completion
- 2014-08-31
Countries
- South Korea
Study Locations
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