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Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer (HIPEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02240524
Recruitment Status : Unknown
Verified September 2014 by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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 lymphadenectomy. It is a multicentric and randomised phase III trial.

Condition or disease Intervention/treatment Phase
Advanced Gastric Adenocarcinoma Procedure: D2 lymphadenectomy Procedure: Systemic chemotherapy Procedure: HIPEC Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy
Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Procedure: D2 lymphadenectomy
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.

Procedure: Systemic chemotherapy
Procedure: HIPEC
Other Name: hyperthermic intraperitoneal chemoperfusion

Placebo Comparator: 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.

Procedure: D2 lymphadenectomy
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.

Procedure: Systemic chemotherapy



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    From the date of surgery to the date of death or to the end of follow-up


Secondary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 5 years ]
    From the date of surgery to the date of recurrence or to the end of follow-up

  2. Locoregional-free survival [ Time Frame: 5 years ]
    From the date of surgery to the date of locoregional recurrence or to the end of follow-up

  3. Hepatic metastases-free survival [ Time Frame: 5 years ]
    From the date of surgery to the date of recurrence or to the end of follow-up



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240524


Contacts
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Contact: zhiyuan fang, Ph.D 86020666736662012 fangjnu@gmail.com

Locations
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China, Guangdong
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510095
Contact: zhiyuan fang, Ph.D    86020666736662012    fangjnu@gmail.com   
Principal Investigator: shuzhong cui, Ph.D         
Sponsors and Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Investigators
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Study Director: shuzhong cui, Ph.D Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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Responsible Party: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02240524    
Other Study ID Numbers: 2014514
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by Affiliated Cancer Hospital & Institute of Guangzhou Medical University:
Gastric adenocarcinoma
HIPEC
Paclitaxel
Oxaliplatin
Capecitabine
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Oxaliplatin
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites