Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer
Conditions
Advanced Gastric Adenocarcinoma
Conditions: official terms
Adenocarcinoma
Conditions: Keywords
Gastric adenocarcinoma, HIPEC, Paclitaxel, Oxaliplatin, Capecitabine
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: D2 lymphadenectomy Type: Procedure
Name: Systemic chemotherapy Type: Procedure
Name: HIPEC Type: Procedure
Overall Status
Recruiting
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 lymphadenectomy. It is a multicentric and randomised phase III trial.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 Criteria:

- 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
Location
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: zhiyuan fang, Ph.D - 86020666736662012 - fangjnu@gmail.com
Start Date
July 2014
Completion Date
July 2019
Sponsors
Affiliated Tumor Hospital of Guangzhou Medical University
Source
Affiliated Tumor Hospital of Guangzhou Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page