Status:
UNKNOWN
Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Conditions:
Advanced Gastric Adenocarcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymp...
Eligibility Criteria
Inclusion
- 18 \< age ≤ 65 years old
- 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
- Existence of macroscopic peritoneal implants
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
582 Patients enrolled
Trial Details
Trial ID
NCT02240524
Start Date
July 1 2014
End Date
July 1 2019
Last Update
September 15 2014
Active Locations (1)
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1
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095