Stomach NeoplasmsGOETHNCT03917173
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study
A study testing Surgery plus HIPEC CO2 and Standard surgery in people with Stomach Neoplasms, run by Mario Negri Institute for Pharmacological Research at 13 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Surgery plus HIPEC CO2 and Standard surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 13 sitesItaly
- Study dates
- 1 Jun 2020to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites, 2 recruiting
- Active, not recruiting
IRCCS Istituto Tumori Giovanni Paolo II
Bari
- Active, not recruiting
AO Santa Croce e Carle
Cuneo
- Active, not recruiting
ULLS1 1 Dolomiti - Ospedale di Feltre
Feltre
- Active, not recruiting
Policlinico di Milano
Milan
- Active, not recruiting
A.O.R.N. A.Cardarelli
Naples
- Active, not recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
- Active, not recruiting
Ospedale Evangelico Betania
Naples
- Active, not recruiting
Azienda Ospedaliera S. Camillo Forlanini
Roma
- Active, not recruiting
Fondazione Policlinico Universitario A. Gemelli
Roma
- Recruiting
Fondazione Policlinico Universitario A. Gemelli
Roma
Alberto Biondi
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore
Roma
Andrea Di Giorgio, MD
- Active, not recruiting
IRCCS Policlinico San Donato
San Donato Milanese
- Active, not recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo
About this study
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
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.
Read the 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.
- Conditions
- Stomach Neoplasms
- Being tested
- Surgery plus HIPEC CO2, Standard surgery
- Keywords
- gastric cancer, HIPEC CO2, Prophylactic surgery, hyperthermic intraperitoneal chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery plus HIPEC CO2Procedure or surgery
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v
Standard surgeryProcedure or surgery
Standard surgery without HIPEC CO2
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin Receives: Procedure: Surgery plus HIPEC CO2 |
| Comparator | Active comparator | Standard surgery Receives: Procedure: Standard surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This outcome measure will be assessed approximately 3 years after the last patient enrolled
Secondary outcomes (8)
Overall Survival
Overall Survival (OS) defined as the time from randomization to the death for any cause
Measured: 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
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.
Measured: 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
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
Measured: This outcome measure will be assessed approximately 3 years after the last patient enrolled
post-surgery complication
number of post-surgery complication
Measured: This outcome measure will be assessed approximately 3 years after the last patient enrolled
duration of surgery
timing of surgery
Measured: This outcome measure will be assessed approximately 3 years after the last patient enrolled
length of hospitalization
duration of hospitalization
Measured: This outcome measure will be assessed approximately 3 years after the last patient enrolled
mortality at 30 and 90 days from surgery
mortality at 30 and 90 days from surgery
Measured: This outcome measure will be assessed at 30 and 90 days from surgery
patients performing the adjuvant chemotherapy.
number of patients performing the adjuvant chemotherapy.
Measured: This outcome measure will be assessed approximately 3 years after the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jun 2020
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Di Giorgio, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917173
- Sponsor's protocol ID
- IRFMN-GCC-7813
- Other IDs
- 2019-001478-27, 2019
- Acronym
- GOETH
- Status last verified
- Oct 2023
- First submitted
- 2 Apr 2019
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36457115
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03917173
- Acronym / sponsor ID
- GOETH / IRFMN-GCC-7813
- Conditions
- Stomach Neoplasms
- Keywords
- gastric cancer, HIPEC CO2, Prophylactic surgery, hyperthermic intraperitoneal chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Surgery plus HIPEC CO2Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin |
| Comparator | Active comparator | Procedure: Standard surgeryStandard surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0.
- Age ≥ 18 years and ≤75 years.
- Written informed consent.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery plus HIPEC CO2Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v | Procedure or surgery | Experimental |
| Standard surgeryStandard surgery without HIPEC CO2 | Procedure or surgery | Comparator |
Primary outcome
Disease free survival
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
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.
8 secondary outcomes
Overall Survival
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
Local recurrence free survival
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
morbidity evaluated during and after surgery
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
post-surgery complication
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
duration of surgery
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
length of hospitalization
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
mortality at 30 and 90 days from surgery
Time frame: This outcome measure will be assessed at 30 and 90 days from surgery
patients performing the adjuvant chemotherapy.
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 36457115Di 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Di Giorgio principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery plus HIPEC CO2 and Standard surgery in people with Stomach Neoplasms, run by Mario Negri Institute for Pharmacological Research at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Di Giorgio, MD (003906 3015 ext. 7255, andrea.digiorgio@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.