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

NCT03348150 | Active Not Recruiting Phase 3 DMC

• 3 other identifiers: M15PEC2015-005695-15NL56123.031.15
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIPEC; Hyperthermic Intraperitoneal Chemotherapy; gastrectomy; cytoreductive surgery; oxaliplatin; docetaxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• progression free survival

  5 years

• treatment-related toxicity

  5 years

• costs and health benefits

  5 years

Study Arms (2)

Gastrecomy + Cytoreductive surgery + HIPEC

EXPERIMENTAL

Gastrectomy combined with cytoreductive surgery and HIPEC (experimental treatment)

Procedure: Cytoreductive surgery + Gastrecomy; Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

palliative systemic chemotherapy

NO INTERVENTION

Palliative systemic chemotherapy only (standard treatment)

Interventions

Cytoreductive surgery + Gastrecomy PROCEDURE

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

Gastrecomy + Cytoreductive surgery + HIPEC

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) DRUG

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

Also known as: HIPEC

Gastrecomy + Cytoreductive surgery + HIPEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• WHO performance status 0-2
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Erasmus Medical Center: collaborator
• UMC Utrecht: collaborator
• University Medical Center Groningen: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (1)

Antoni van Leeuwenhoek/ Netherlands Cancer institute

Amsterdam, 1066CZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 28705789 BACKGROUND

• 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.

  PMID: 31060544 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Cytoreduction Surgical Procedures; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Johanna van Sandick, MD, PHD

  Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: October 1, 2017
• Primary Completion: September 17, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)