NCT03917173: GOETH

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study

Status unknown NA Last updated 26 October 2023

What this trial tests

NA trial testing Surgery plus HIPEC CO2 in Stomach Neoplasms in 240 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
1 June 2025

1 June 2025

Quick facts

Lead sponsor	Mario Negri Institute for Pharmacological Research
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	1 June 2020
Primary completion	1 June 2025
Estimated completion	1 June 2025
Sites	13 locations across Italy

Drugs / interventions tested

• Surgery plus HIPEC CO2
• Standard surgery

Conditions studied

• Stomach Neoplasms — all drugs for Stomach Neoplasms →

Sponsor

Mario Negri Institute for Pharmacological Research

Who can join

Adults 18 to 75, any sex, with Stomach Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
* comparator: standard surgery

Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility in both arms.

Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hyperthermic intraperitoneal chemotherapy in prevention of gastric cancer metachronous peritoneal metastases: a systematic review.
   Reutovich MY, Krasko OV, Sukonko OG. · · 2021 · cited 17× · PMID 33968422 · DOI 10.21037/jgo-20-129
2. Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery for gastric carcinoma at high risk of peritoneal carcinomatosis: short and long-term outcomes (GOETH STUDY)-a collaborative randomized controlled trial by ACOI, FONDAZIONE AIOM
   Di Giorgio A, Gerardi C, Abatini C, Melotti G, et al · · 2022 · cited 11× · PMID 36457115 · DOI 10.1186/s13063-022-06880-y
3. Update of randomized controlled trials evaluating cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in prevention and therapy of peritoneal metastasis: a systematic review.
   Noiret B, Piessen G, Eveno C. · · 2022 · cited 8× · PMID 35812007 · DOI 10.1515/pp-2021-0152
4. Current Research and Development in Hyperthermic Intraperitoneal Chemotherapy (HIPEC)-A Cross-Sectional Analysis of Clinical Trials Registered on ClinicalTrials.gov.
   Ukegjini K, Guidi M, Lehmann K, Süveg K, et al · · 2023 · cited 7× · PMID 37046587 · DOI 10.3390/cancers15071926
5. Role of prophylactic HIPEC in non-metastatic, serosa-invasive gastric cancer: a literature review.
   Kunte AR, Parray AM, Bhandare MS, Solanki SL. · · 2022 · cited 4× · PMID 36159214 · DOI 10.1515/pp-2022-0104
6. Executive Summary of the American Radium Society Appropriate Use Criteria for the Management of Peritoneal Carcinomatosis From Different Tumor Origins: Systematic Review and Guidelines.
   Expert Panel Management of Peritoneal Carcinomatosis, Kennedy T, Singh S, Abood G, et al · · 2025 · cited 1× · PMID 40693544 · DOI 10.1002/cam4.71043