Back to results

Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

Primary Purpose

Malignant Neoplasm of Stomach

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Hyperthermic intraperitoneal chemotherapy (HIPEC)

D2 radical gastrectomy

SOX postoperative chemotherapy

XELOX postoperative chemotherapy

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Stomach

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological proved diagnosis of locally advanced gastric cancer.
No evidence of distant metastases or peritoneal metastases.
Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
Eligible for radical gastrectomy with D2 lymphadenectomy.
Have not received cytotoxic chemotherapy or radiotherapy.
Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

Existence of distant metastasis or peritoneal metastasis during surgery (M1).
Any previous chemotherapy or radiotherapy
Active systemic infections
Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
Female patients who are pregnant or breast feeding

Sites / Locations

Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Radical gastrectomy without HIPEC

Radical gastrectomy with HIPEC

Arm Description

Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX)

Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX)

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

progression-free survival

distant metastasis rate

peritoneal metastasis rate

local recurrence rate

complication rate

Full Information

NCT ID

NCT02528110

First Posted

August 16, 2015

Last Updated

March 22, 2020

Sponsor

Wuhan University

1. Study Identification

Unique Protocol Identification Number

NCT02528110

Brief Title

Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

Official Title

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

March 10, 2020 (Actual)

Study Completion Date

March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.

Detailed Description

To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death. The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Neoplasm of Stomach

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radical gastrectomy without HIPEC

Arm Type

Sham Comparator

Arm Description

Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX)

Arm Title

Radical gastrectomy with HIPEC

Arm Type

Experimental

Arm Description

Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX)

Intervention Type

Procedure

Intervention Name(s)

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Intervention Description

Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.

Intervention Type

Procedure

Intervention Name(s)

D2 radical gastrectomy

Intervention Description

radical gastrectomy with D2 lymphadenectomy

Intervention Type

Other

Intervention Name(s)

SOX postoperative chemotherapy

Intervention Description

Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.

Intervention Type

Other

Intervention Name(s)

XELOX postoperative chemotherapy

Intervention Description

Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.

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

progression-free survival

Time Frame

5 years

Title

distant metastasis rate

Time Frame

5 years

Title

peritoneal metastasis rate

Time Frame

5 years

Title

local recurrence rate

Time Frame

5 years

Title

complication rate

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological proved diagnosis of locally advanced gastric cancer. No evidence of distant metastases or peritoneal metastases. Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage. Eligible for radical gastrectomy with D2 lymphadenectomy. Have not received cytotoxic chemotherapy or radiotherapy. Written informed consent is obtained prior to commencement of trial treatment. Exclusion Criteria: Existence of distant metastasis or peritoneal metastasis during surgery (M1). Any previous chemotherapy or radiotherapy Active systemic infections Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. Female patients who are pregnant or breast feeding

Facility Information:

Facility Name

Zhongnan Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430021

Country

China

12. IPD Sharing Statement

Learn more about this trial

Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

We'll reach out to this number within 24 hrs