Back to resultsProphylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study (GOETH)
Primary Purpose
Stomach Neoplasms
Status
Recruiting
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Surgery plus HIPEC CO2
Standard surgery
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring gastric cancer, HIPEC CO2, Prophylactic surgery, hyperthermic intraperitoneal chemotherapy
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Sites / Locations
- IRCCS Istituto Tumori Giovanni Paolo II
- AO Santa Croce e Carle
- ULLS1 1 Dolomiti - Ospedale di Feltre
- Policlinico di Milano
- A.O.R.N. A.Cardarelli
- Azienda Ospedaliera Universitaria Federico II
- Ospedale Evangelico Betania
- Azienda Ospedaliera S. Camillo Forlanini
- Fondazione Policlinico Universitario A. Gemelli
- Fondazione Policlinico Universitario A. GemelliRecruiting
- Fondazione Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro CuoreRecruiting
- IRCCS Policlinico San Donato
- IRCCS Casa Sollievo della Sofferenza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Comparator
Arm Description
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
Standard surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival
Overall Survival (OS) defined as the time from randomization to the death for any cause
Local recurrence free survival
Local recurrence free survival (LRFS) defined as the time from randomization defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.
morbidity evaluated during and after surgery
morbidity evaluated during and after surgery graded according to the NCI-CTAE version 4.03 for AE related to chemotherapy and according to Clavien Dindo for surgery complications
post-surgery complication
number of post-surgery complication
duration of surgery
timing of surgery
length of hospitalization
duration of hospitalization
mortality at 30 and 90 days from surgery
mortality at 30 and 90 days from surgery
patients performing the adjuvant chemotherapy.
number of patients performing the adjuvant chemotherapy.
Full Information
NCT ID
NCT03917173
First Posted
April 2, 2019
Last Updated
June 16, 2021
Sponsor
Mario Negri Institute for Pharmacological Research
1. Study Identification
Unique Protocol Identification Number
NCT03917173
Brief Title
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study
Acronym
GOETH
Official Title
Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Gastric Carcinoma at High Risk of Developing Peritoneal Carcinomatosis. Short and Long-term Outcomes Evaluation.A Collaborative Randomized Controlled Trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. GOETH STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mario Negri Institute for Pharmacological Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
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.
The primary objective of the study is to compare the efficacy of prophylactic surgery (radical gastric resection, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 versus standard surgery in terms of disease free survival (DFS).
Patients affected by gastric carcinoma at high risk of developing peritoneal carcinomatosis will be randomized in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
gastric cancer, HIPEC CO2, Prophylactic surgery, hyperthermic intraperitoneal chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model 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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Standard surgery
Intervention Type
Procedure
Intervention Name(s)
Surgery plus HIPEC CO2
Intervention Description
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v
Intervention Type
Procedure
Intervention Name(s)
Standard surgery
Intervention Description
Standard surgery without HIPEC CO2
Primary Outcome Measure Information:
Title
Disease free survival
Description
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.
Time Frame
This outcome measure will be assessed approximately 3 years after the last patient enrolled
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival (OS) defined as the time from randomization to the death for any cause
Time Frame
This outcome measure will be assessed approximately 3 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Local recurrence free survival
Description
Local recurrence free survival (LRFS) defined as the time from randomization defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.
Time Frame
This outcome measure will be assessed approximately 3 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
morbidity evaluated during and after surgery
Description
morbidity evaluated during and after surgery graded according to the NCI-CTAE version 4.03 for AE related to chemotherapy and according to Clavien Dindo for surgery complications
Time Frame
This outcome measure will be assessed approximately 3 years after the last patient enrolled
Title
post-surgery complication
Description
number of post-surgery complication
Time Frame
This outcome measure will be assessed approximately 3 years after the last patient enrolled
Title
duration of surgery
Description
timing of surgery
Time Frame
This outcome measure will be assessed approximately 3 years after the last patient enrolled
Title
length of hospitalization
Description
duration of hospitalization
Time Frame
This outcome measure will be assessed approximately 3 years after the last patient enrolled
Title
mortality at 30 and 90 days from surgery
Description
mortality at 30 and 90 days from surgery
Time Frame
This outcome measure will be assessed at 30 and 90 days from surgery
Title
patients performing the adjuvant chemotherapy.
Description
number of patients performing the adjuvant chemotherapy.
Time Frame
This outcome measure will be assessed approximately 3 years after the last patient enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Di Giorgio, MD
Phone
003906 3015
Ext
7255
Email
andrea.digiorgio@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Rulli
Phone
0039023901
Ext
4684
Email
erica.rulli@marionegri.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Di Giorgio
Organizational Affiliation
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Tumori Giovanni Paolo II
City
Bari
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AO Santa Croce e Carle
City
Cuneo
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ULLS1 1 Dolomiti - Ospedale di Feltre
City
Feltre
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Policlinico di Milano
City
Milano
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O.R.N. A.Cardarelli
City
Napoli
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Evangelico Betania
City
Napoli
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera S. Camillo Forlanini
City
Roma
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione Policlinico Universitario A. Gemelli
City
Roma
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione Policlinico Universitario A. Gemelli
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Biondi
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Di Giorgio, MD
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study
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