NCT04345770

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

5 years

First QC Date

April 10, 2020

Last Update Submit

April 10, 2020

Conditions

Malignant Neoplasm of Stomach

Outcome Measures

Primary Outcomes (1)

  • overall survival

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

    5 years

Secondary Outcomes (5)

  • progression-free survival

    5 years

  • distant metastasis rate

    5 years

  • peritoneal metastasis rate

    5 years

  • local recurrence rate

    5 years

  • complication rate

    5 years

Study Arms (2)

Without HIPEC

SHAM COMPARATOR

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)

Procedure: D2 radical gastrectomyDrug: SOX neoadjuvant or postoperative chemotherapy

With HIPEC

EXPERIMENTAL

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)

Procedure: D2 radical gastrectomyDrug: SOX neoadjuvant or postoperative chemotherapyProcedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)

Interventions

D2 radical gastrectomyPROCEDURE

radical gastrectomy with D2 lymphadenectomy

Also known as: Surgery
With HIPECWithout HIPEC
SOX neoadjuvant or postoperative chemotherapyDRUG

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

Also known as: Chemotherapy
With HIPECWithout HIPEC
Hyperthermic intraperitoneal chemotherapy (HIPEC)PROCEDURE

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

Also known as: HIPEC
With HIPEC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan University

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surgical Procedures, OperativeDrug TherapyHyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsChemotherapy, AdjuvantCombined Modality TherapyHyperthermia, Induced

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastrointestinal Surgery Department

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 14, 2020

Study Start

April 1, 2020

Primary Completion

March 31, 2025

Study Completion

May 31, 2025

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

CN(1)