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

NCT03917173 | Unknown DMC

• 2 other identifiers: IRFMN-GCC-78132019-001478-27
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Stomach Neoplasms

Keywords

gastric cancer; HIPEC CO2; Prophylactic surgery; hyperthermic intraperitoneal chemotherapy

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  The primary efficacy endpoint is DFS defined as the time from randomization to the date of first local relapse or distant relapse or peritoneal carcinomatosis or death for any cause, whichever comes first.

  This outcome measure will be assessed approximately 3 years after the last patient enrolled

Secondary Outcomes (8)

• Overall Survival

  This outcome measure will be assessed approximately 3 years after the last patient enrolled, at the same time points of the Primary Endpoint

• Local recurrence free survival

  This outcome measure will be assessed approximately 3 years after the last patient enrolled, at the same time points of the Primary Endpoint

• morbidity evaluated during and after surgery

  This outcome measure will be assessed approximately 3 years after the last patient enrolled

• post-surgery complication

  This outcome measure will be assessed approximately 3 years after the last patient enrolled

• duration of surgery

  This outcome measure will be assessed approximately 3 years after the last patient enrolled

Study Arms (2)

Experimental

EXPERIMENTAL

Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin

Procedure: Surgery plus HIPEC CO2

Comparator

ACTIVE COMPARATOR

Standard surgery

Procedure: Standard surgery

Interventions

Surgery plus HIPEC CO2 PROCEDURE

Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v

Experimental

Standard surgery PROCEDURE

Standard surgery without HIPEC CO2

Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0.
• Presurgical or intraoperative stage T3-T4 N0-N+ primary tumour (TNM 8 th).
• Urgent presentation: perforation without purulent generalized peritonitis
• Positive cytology of peritoneal fluid (if previously obtained)
• Age ≥ 18 years and ≤75 years.
• Written informed consent.

You may not qualify if:

• Gastroesophageal Junction (GEJ) cancer
• Distant metastatic disease (even if limited and completely resected)
• Peritoneal carcinomatosis
• History of tumor diagnosed in the 3 years before entering the study, except for topical and healed pathologies that do not need further treatment (e.g. non-melanoma skin carcinomas, superficial bladder carcinomas or in situ carcinoma of the breast or cervix).
• Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
• Poor general conditions (ECOG \> 2).
• Impaired cardiac function (history of congestive heart failure or FE \<40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class \> II) or serious uncontrolled cardiac Arrhythmia requiring medication
• Impaired renal function (creatinine\> 1.5 upper limit of normal or creatinine clearance \<60 mL / min).
• Impaired hepatic function (AST, ALT \>2.5 upper limit of normal, bilirubin \> 1.5 upper limit of normal).
• Impaired hematopoietic function (leucocytes \<4000 / mm3, neutrophils \<1500 / mm 3, platelets \<100000 / mm3).
• Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 \<50% or DLCO \<40% of normal age value).
• History or presence of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of HIPEC or chemotherapy or patient at high risk from treatment complications.
• Pregnancy.
• Krukenberg tumor
• Refusal to join the study.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (13)

IRCCS Istituto Tumori Giovanni Paolo II

Bari, Italy

ACTIVE NOT RECRUITING

AO Santa Croce e Carle

Cuneo, Italy

ACTIVE NOT RECRUITING

ULLS1 1 Dolomiti - Ospedale di Feltre

Feltre, Italy

ACTIVE NOT RECRUITING

Policlinico di Milano

Milan, Italy

ACTIVE NOT RECRUITING

A.O.R.N. A.Cardarelli

Napoli, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

ACTIVE NOT RECRUITING

Ospedale Evangelico Betania

Napoli, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera S. Camillo Forlanini

Roma, Italy

ACTIVE NOT RECRUITING

Fondazione Policlinico Universitario A. Gemelli

Roma, Italy

ACTIVE NOT RECRUITING

Fondazione Policlinico Universitario A. Gemelli

Roma, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore

Roma, Italy

RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, Italy

ACTIVE NOT RECRUITING

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

ACTIVE NOT RECRUITING

Related Publications (1)

• Di Giorgio A, Gerardi C, Abatini C, Melotti G, Bonavina L, Torri V, Santullo F, Garattini S, De Luca M, Rulli E, Rulli E, Pacelli F; GOETH Investigators. 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, SIC, SICE, and SICO. Trials. 2022 Dec 1;23(1):969. doi: 10.1186/s13063-022-06880-y.

  PMID: 36457115 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Di Giorgio

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Di Giorgio, MD

CONTACT

003906 3015; andrea.digiorgio@policlinicogemelli.it

Erica Rulli

CONTACT

0039023901; erica.rulli@marionegri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 16, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13)