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Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination.

NCT03348150 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-07-17

No results posted yet for this study

Summary

A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC (experimental arm) and palliative systemic chemotherapy (standard arm).

Conditions

  • Stomach Neoplasm
  • Peritoneal Carcinomatosis

Interventions

PROCEDURE

Cytoreductive surgery + Gastrecomy

Complete cytoreduction followed by a (sub)total gastric resection with D2 lymphadenectomy.

DRUG

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

HIPEC: perfusion with oxaliplatin (460mg/m2 ) (42 °C) followed by docetaxel (50mg/m2 ) (37°C)

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • University Medical Center Groningen

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Johanna van Sandick, MD, PHD · Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2025-09-17
Completion
2027-10-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348150 on ClinicalTrials.gov