Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

NCT ID: NCT04345770

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Malignant Neoplasm of Stomach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Without HIPEC

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)

Group Type SHAM_COMPARATOR

D2 radical gastrectomy

Intervention Type PROCEDURE

radical gastrectomy with D2 lymphadenectomy

SOX neoadjuvant or postoperative chemotherapy

Intervention Type DRUG

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

With HIPEC

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)

Group Type EXPERIMENTAL

D2 radical gastrectomy

Intervention Type PROCEDURE

radical gastrectomy with D2 lymphadenectomy

SOX neoadjuvant or postoperative chemotherapy

Intervention Type DRUG

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

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Intervention Type PROCEDURE

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

Interventions

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D2 radical gastrectomy

radical gastrectomy with D2 lymphadenectomy

Intervention Type PROCEDURE

SOX neoadjuvant or postoperative chemotherapy

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

Intervention Type DRUG

Hyperthermic intraperitoneal chemotherapy (HIPEC)

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

Intervention Type PROCEDURE

Other Intervention Names

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Surgery Chemotherapy HIPEC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Bin Xiong, MD

Director of Gastrointestinal Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Bin Xiong

Role: primary

+86 27 67813152

Other Identifiers

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WuhanZN_HIPEC

Identifier Type: -

Identifier Source: org_study_id

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