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
- Diseases
- Gastric and esophageal cancer
- 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
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Active, not recruiting |
| Ziekenhuisgroep Twente Stichting Coordinator of this site? Confirm its status | Almelo | Netherlands | Active, not recruiting |
| Flevoziekenhuis Stichting Coordinator of this site? Confirm its status | Almere | Netherlands | Active, not recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Gelre Hospitals Coordinator of this site? Confirm its status | Apeldoorn | Netherlands | Active, not recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Active, not recruiting |
| Stichting St. Anna Zorggroep Coordinator of this site? Confirm its status | Geldrop | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Ziekenhuis St Jansdal Coordinator of this site? Confirm its status | Harderwijk | Netherlands | Active, not recruiting |
| Medisch Centrum Leeuwarden B.V. Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Ikazia Ziekenhuis Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Active, not recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.