NCT02528110

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

4.6 years

First QC Date

August 16, 2015

Last Update Submit

March 22, 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)

Radical gastrectomy without HIPEC

SHAM COMPARATOR

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

Procedure: D2 radical gastrectomyOther: SOX postoperative chemotherapyOther: XELOX postoperative chemotherapy

Radical gastrectomy with HIPEC

EXPERIMENTAL

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)

Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)Procedure: D2 radical gastrectomyOther: SOX postoperative chemotherapyOther: XELOX postoperative chemotherapy

Interventions

Hyperthermic intraperitoneal chemotherapy (HIPEC)PROCEDURE

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

Radical gastrectomy with HIPEC
D2 radical gastrectomyPROCEDURE

radical gastrectomy with D2 lymphadenectomy

Radical gastrectomy with HIPECRadical gastrectomy without HIPEC
SOX postoperative chemotherapyOTHER

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

Radical gastrectomy with HIPECRadical gastrectomy without HIPEC
XELOX postoperative chemotherapyOTHER

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

Radical gastrectomy with HIPECRadical gastrectomy without 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)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430021, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug 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
Cancer Center of Wuhan University

Study Record Dates

First Submitted

August 16, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

CN(1)