Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
NCT ID: NCT02528110
Last Updated: 2020-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2015-08-31
2020-03-10
Brief Summary
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Detailed Description
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The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radical gastrectomy without HIPEC
Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX)
D2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy
SOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
XELOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Radical gastrectomy with HIPEC
Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX)
Hyperthermic intraperitoneal chemotherapy (HIPEC)
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
D2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy
SOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
XELOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Interventions
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Hyperthermic intraperitoneal chemotherapy (HIPEC)
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
D2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy
SOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
XELOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Eligibility Criteria
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Inclusion Criteria
* No evidence of distant metastases or peritoneal metastases.
* Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
* Eligible for radical gastrectomy with D2 lymphadenectomy.
* Have not received cytotoxic chemotherapy or radiotherapy.
* Written informed consent is obtained prior to commencement of trial treatment.
Exclusion Criteria
* Any previous chemotherapy or radiotherapy
* Active systemic infections
* Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
* Female patients who are pregnant or breast feeding
18 Years
75 Years
ALL
No
Sponsors
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Wuhan University
OTHER
Responsible Party
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Bin Xiong, MD
Cancer Center of Wuhan University
Locations
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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Other Identifiers
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WuhanU_HIPEC
Identifier Type: -
Identifier Source: org_study_id
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