Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
NCT02528110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-03-24
Summary
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.
Conditions
- Malignant Neoplasm of Stomach
Interventions
- PROCEDURE
-
Hyperthermic intraperitoneal chemotherapy (HIPEC)
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
- PROCEDURE
-
D2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy
- OTHER
-
SOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
- OTHER
-
XELOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Sponsors & Collaborators
-
Wuhan University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-31
- Primary Completion
- 2020-03-10
- Completion
- 2020-03-10
Countries
- China
Study Locations
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