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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Peritoneal Carcinomatosis; Stomach Neoplasm
• Intervention / Treatment: Procedure: Cytoreductive surgery + Gastrecomy; Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Detailed Description

Rationale: For gastric cancer patients with peritoneal carcinomatosis palliative systemic chemotherapy is the standard treatment in the Netherlands. There are no potentially curative treatment options. Peritoneal carcinomatosis, in contrast to lymphatic and haematogenous dissemination, should be regarded as locoregional extension of disease. Administering chemotherapeutic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations of cytotoxic drugs can be delivered directly into the peritoneal cavity with little systemic toxicity. The combination of intraperitoneally administered chemotherapy with cytoreductive surgery and a radical gastrectomy has shown promising results in gastric cancer patients in Asia. As with other gastric cancer issues, the results obtained in Asian patients cannot be extrapolated directly to Western patients.

Objective: The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.

Study design : This is a multicentre randomised controlled two-armed phase III trial. Patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy combined with cytoreductive surgery and HIPEC (experimental treatment).

Study population: Gastric cancer patients are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal carcinomatosis (<7) and/ or tumour positive cytology is confirmed by laparoscopy or laparotomy, and (3) systemic chemotherapy (prior to inclusion) was without disease progression.

Main study parameters/endpoints: The study sample size (182 patients) is calculated from the hypothesis that the median overall survival of the patients treated according to protocol in the experimental arm is 18 months, as compared to a median overall survival of 10 months in the standard arm. Statistical analysis will be done according to the intention-to-treat principle.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CZ
    • Antoni van Leeuwenhoek/ Netherlands Cancer institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
• Recurrent gastric cancer
• Prior resection of the primary gastric tumour
• Non-synchronous peritoneal carcinomatosis
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastrecomy + Cytoreductive surgery + HIPEC; Gastrectomy combined with cytoreductive surgery and HIPEC (experimental treatment)	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); Other Names: HIPEC
No Intervention: palliative systemic chemotherapy; Palliative systemic chemotherapy only (standard treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	To compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	To compare the progression free survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.	5 years
treatment-related toxicity	To study treatment-related toxicity in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC.	5 years
costs and health benefits	To compare the costs and health benefits of a gastrectomy in combination with cytoreductive surgery and HIPEC, to the costs and health benefits of standard palliative systemic chemotherapy in patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology.	5 years

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: University Medical Center Groningen; UMC Utrecht; Erasmus Medical Center; Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: Johanna van Sandick, MD, PHD, Surgeon

Publications and helpful links

General Publications

• van der Kaaij RT, Braam HJ, Boot H, Los M, Cats A, Grootscholten C, Schellens JH, Aalbers AG, Huitema AD, Knibbe CA, Boerma D, Wiezer MJ, van Ramshorst B, van Sandick JW. Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR Res Protoc. 2017 Jul 13;6(7):e136. doi: 10.2196/resprot.7790.
• Koemans WJ, van der Kaaij RT, Boot H, Buffart T, Veenhof AAFA, Hartemink KJ, Grootscholten C, Snaebjornsson P, Retel VP, van Tinteren H, Vanhoutvin S, van der Noort V, Houwink A, Hahn C, Huitema ADR, Lahaye M, Los M, van den Barselaar P, Imhof O, Aalbers A, van Dam GM, van Etten B, Wijnhoven BPL, Luyer MDP, Boerma D, van Sandick JW. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II). BMC Cancer. 2019 May 6;19(1):420. doi: 10.1186/s12885-019-5640-2.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Estimated): September 17, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: oxaliplatin; cytoreductive surgery; HIPEC; docetaxel; gastrectomy; Hyperthermic Intraperitoneal Chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Abdominal Neoplasms; Stomach Neoplasms; Carcinoma; Peritoneal Neoplasms
• Other Study ID Numbers: M15PEC; 2015-005695-15 (EudraCT Number); NL56123.031.15 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No