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

Primary Purpose

Advanced Gastric Adenocarcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
D2 lymphadenectomy
Systemic chemotherapy
HIPEC
Sponsored by
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Adenocarcinoma focused on measuring Gastric adenocarcinoma, HIPEC, Paclitaxel, Oxaliplatin, Capecitabine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D2 lymphadenectomy and HIPEC and Systemic chemotherapy

D2 lymphadenectomy+Systemic chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival
From the date of surgery to the date of death or to the end of follow-up

Secondary Outcome Measures

Recurrence-free survival
From the date of surgery to the date of recurrence or to the end of follow-up
Locoregional-free survival
From the date of surgery to the date of locoregional recurrence or to the end of follow-up
Hepatic metastases-free survival
From the date of surgery to the date of recurrence or to the end of follow-up

Full Information

First Posted
June 3, 2014
Last Updated
September 12, 2014
Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02240524
Brief Title
Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer
Acronym
HIPEC
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Adenocarcinoma
Keywords
Gastric adenocarcinoma, HIPEC, Paclitaxel, Oxaliplatin, Capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
582 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D2 lymphadenectomy and HIPEC and Systemic chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
D2 lymphadenectomy+Systemic chemotherapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
D2 lymphadenectomy
Intervention Description
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
Intervention Type
Procedure
Intervention Name(s)
Systemic chemotherapy
Intervention Type
Procedure
Intervention Name(s)
HIPEC
Other Intervention Name(s)
hyperthermic intraperitoneal chemoperfusion
Primary Outcome Measure Information:
Title
Overall survival
Description
From the date of surgery to the date of death or to the end of follow-up
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Recurrence-free survival
Description
From the date of surgery to the date of recurrence or to the end of follow-up
Time Frame
5 years
Title
Locoregional-free survival
Description
From the date of surgery to the date of locoregional recurrence or to the end of follow-up
Time Frame
5 years
Title
Hepatic metastases-free survival
Description
From the date of surgery to the date of recurrence or to the end of follow-up
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhiyuan fang, Ph.D
Phone
86020666736662012
Email
fangjnu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shuzhong cui, Ph.D
Organizational Affiliation
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhiyuan fang, Ph.D
Phone
86020666736662012
Email
fangjnu@gmail.com
First Name & Middle Initial & Last Name & Degree
shuzhong cui, Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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