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Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

Primary Purpose

Malignant Neoplasm of Stomach

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

D2 radical gastrectomy

SOX neoadjuvant or postoperative chemotherapy

Hyperthermic intraperitoneal chemotherapy (HIPEC)

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

Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Without HIPEC

With HIPEC

Arm Description

Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)

Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)

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

NCT04345770

First Posted

April 10, 2020

Last Updated

April 10, 2020

Sponsor

Wuhan University

1. Study Identification

Unique Protocol Identification Number

NCT04345770

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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 combined with 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 neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death. The trial is designed as a prospective, randomized, open 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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Without HIPEC

Arm Type

Sham Comparator

Arm Description

Arm Title

With HIPEC

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

D2 radical gastrectomy

Other Intervention Name(s)

Surgery

Intervention Description

radical gastrectomy with D2 lymphadenectomy

Intervention Type

Drug

Intervention Name(s)

SOX neoadjuvant or postoperative chemotherapy

Other Intervention Name(s)

Chemotherapy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Other Intervention Name(s)

HIPEC

Intervention Description

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

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

Wuhan University

City

Wuhan

State/Province

Hubei

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bin Xiong

Phone

+86 27 67813152

jyn1983@163.com

12. IPD Sharing Statement

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Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

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