Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUkrainian Society of Clinical Oncology

About this trial

The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80

Hystologicaly proven gastric adenocarcinoma

ECOG status 0-1

Written consent to participate in the study

Disqualifiers

Pregnancy/breastfeeding

ECOG status 2-4

Concomitant malignancy

Mitomycin and/or Cisplatin hypersensitivity

Trial population

The study population will consist of adult patients receiving care at oncological centers in Ukraine who meet all predefined eligibility criteria for this study. Investigators include individuals with for which Gastrectomy+HIPEC is considered an accepted or potentially beneficial treatment option according to national and international clinical guidelines. Participants will be recruited from tertiary surgical oncology hospitals and specialized cancer institutes across Ukraine.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • curative-intent surgery + HIPEC

    Procedure/Surgery

    Participants enrolled in this study will undergo curative-intent gastrectomy for gastric cancer, immediately followed by Hyperthermic Intraperitoneal Chemotherapy (HIPEC) performed during the same operative session. Dosage of drugs: mitomycin C 15 mg/m2, cisplatin 75mg/m2. The procedure is conducted according to a standardized protocol in National Cancer Institute

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Prophylactic cohort (T4a/T4b/cyt+)1 intervention
Group B: Low PCI cohort (PCI<7)1 intervention

Trial outcomes

Primary outcomes

1

Peritoneal recurrence rate

Number of patients developed peritoneal recurence

Time frame
From enrolment up to 5 years of follow-up

Secondary outcomes

1

Distant recurrence rate

Time from diagnosis to distant reccurence

Time frame
Time from diagnosis up to 5 years of follow-up
2

Intraperitoneal chemotherapy complications rate

Complications rate assessed by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade from 1 to 5)

Time frame
30 days after chemotherapy
3

Postoperative complications rate

Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5)

Time frame
30 days after surgery
4

5-years overall survival

5-years overall survival

Time frame
From the time of diagnosis up to 5 years of follow-up

Other outcomes

Sponsors and contacts

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