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NCT03348150Active, not recruitingPhase 3

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

Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).

Source: ClinicalTrials.gov · Last updated 17 Jul 2025

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
102 (estimated)
First submitted
15 Nov 2017
Start date
1 Oct 2017
Primary completion date
17 Sept 2025
Lead sponsor
The Netherlands Cancer Institute
NCT number
NCT03348150
EU CT number
2023-510159-53-01
EudraCT number
2015-005695-15

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 102
  • From 1 Oct 2017 to the primary completion date, 17 Sept 2025
  • 18 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior resection of the primary gastric tumour

Other illness

  • Recurrent gastric cancer
  • Current other malignancy (other than cervix carcinoma and basalioma)
  • Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2
  • A known history of hepatitis B or C with active viral replication
  • Recent myocardial infarction (\< 6 months) or unstable angina
  • Any medical condition not yet specified above that is considered to interfere with study procedures, including adequate follow-up and compliance and/or would jeopardise safe treatment
  • Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents

Other

  • Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
  • Non-synchronous peritoneal carcinomatosis

Who the study is looking for

  • Age ≥ 18 years
  • Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary.
  • cT3-cT4 tumour (TNM classification, 7th edition), considered to be resectable (including lymph nodes)
  • Limited peritoneal carcinomatosis (PCI \<7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy and proven by pathological examination
  • Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion. All currently standard chemotherapy regimens are acceptable
  • Absence of disease progression during systemic chemotherapy (prior to inclusion)
  • WHO performance status 0-2
  • Adequate bone marrow, hepatic and renal function. Minimally acceptable laboratory values at start of the study inclusion:
    • ANC ≥ 1.5 x 109 /L
    • Platelet count ≥ 100 x 109 /L
    • Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN
    • Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula)
  • For female patients who are not sterilised or in menopause (i.e., amenorrhea ≥1 year if age ≥60 years, or ≥2 years if age \<60 years):
    • negative pregnancy test (urine/serum)
    • no breast feeding or active pregnancy ambition
    • reliable contraceptive methods
  • Signed informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus Universitetshospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkActive, not recruiting
Oulu University Hospital
Coordinator of this site? Confirm its status
OuluFinlandActive, not recruiting
Ziekenhuisgroep Twente Stichting
Coordinator of this site? Confirm its status
AlmeloNetherlandsActive, not recruiting
Flevoziekenhuis Stichting
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AlmereNetherlandsActive, not recruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsActive, not recruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Gelre Hospitals
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ApeldoornNetherlandsActive, not recruiting
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsActive, not recruiting
Stichting St. Anna Zorggroep
Coordinator of this site? Confirm its status
GeldropNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Ziekenhuis St Jansdal
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HarderwijkNetherlandsActive, not recruiting
Medisch Centrum Leeuwarden B.V.
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LeeuwardenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Ikazia Ziekenhuis
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RotterdamNetherlandsActive, not recruiting
Jeroen Bosch Ziekenhuis
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's-HertogenboschNetherlandsActive, not recruiting
Elisabeth-Tweesteden Ziekenhuis
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TilburgNetherlandsActive, not recruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.