Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer
NCT ID: NCT02240524
Last Updated: 2014-09-15
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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UNKNOWN
PHASE3
582 participants
INTERVENTIONAL
2014-07-31
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D2 lymphadenectomy and HIPEC and Systemic chemotherapy
Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy.
HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m\^2, 43°C, 60min.
Systemic chemotherapy (XELOX):
Oxaliplatin: 130mg/m\^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m\^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.
D2 lymphadenectomy
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
Systemic chemotherapy
HIPEC
D2 lymphadenectomy+Systemic chemotherapy
8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy.
Systemic chemotherapy (XELOX):
Oxaliplatin: 130mg/m\^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m\^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.
D2 lymphadenectomy
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
Systemic chemotherapy
Interventions
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D2 lymphadenectomy
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
Systemic chemotherapy
HIPEC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or Non pregnant female
* The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
* Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan)
* Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
* White blood cells \> 4,000/mm3
* neutrophils ≥ 1,500/mm3
* platelets ≥ 100,000/mm3
* hemoglobin\>9g/l
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN)
* total bilirubin (TBIL) \< 1.5 times ULN
* serum creatinine \< 1 times ULN
* Having given written informed consent prior to any procedure related to the study
Exclusion Criteria
* Prior malignant tumors with detectable signs of recurrence or distant metastasis
* Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
* Receiving other cytotoxic chemotherapy
* High grade of intra-abdominal adhesions
* Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent
18 Years
65 Years
ALL
No
Sponsors
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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shuzhong cui, Ph.D
Role: STUDY_DIRECTOR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Locations
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Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014514
Identifier Type: -
Identifier Source: org_study_id
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