Treatment Strategy for Stage IV Gastric Cancer with Positive Peritoneal Cytology As the Only Non-curable Factor
NCT02969122 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2024-09-19
Summary
Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging system. Controversy exists on the treatment of this part of patients. This trial aimed to explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal cytology as the only non-curable factor.
Conditions
- Stomach Neoplasm
Interventions
- PROCEDURE
-
standard gastrectomy with D2 lymphadenectomy
standard distal or total gastrectomy and accorded D2 lymphadenectomy
- PROCEDURE
-
hyperthermic intraperitoneal chemotherapy
Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes
- PROCEDURE
-
Extensive intraperitoneal lavage
Lavage of peritoneal cavity with 1000ml saline for 10 times
- OTHER
-
Preoperative chemotherapy
Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.
- OTHER
-
Postoperative chemotherapy
SOX regimen postoperative chemotherapy (Oxaliplatin 130mg/m2 D1, S-1 40-60mg Bid D1-14, Repeated every 3 weeks) for surgery-first arm. Regimen for chemotherapy-first arm is determined according to the postoperative pathologic evaluation of response.
Sponsors & Collaborators
-
Peking University
lead OTHER
Principal Investigators
-
Jiafu Ji, M.D. · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2024-09-09
- Completion
- 2024-09-09
Countries
- China
Study Locations
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