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

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ClinicalTrials.gov Identifier: NCT03917173
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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.


Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: Surgery plus HIPEC CO2 Procedure: Standard surgery Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Experimental
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
Procedure: Surgery plus HIPEC CO2
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v

Active Comparator: Comparator
Standard surgery
Procedure: Standard surgery
Standard surgery without HIPEC CO2




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Overall Survival (OS) defined as the time from randomization to the death for any cause

  2. 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 ]
    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.

  3. morbidity evaluated during and after surgery [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    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

  4. post-surgery complication [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    number of post-surgery complication

  5. duration of surgery [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    timing of surgery

  6. length of hospitalization [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    duration of hospitalization

  7. mortality at 30 and 90 days from surgery [ Time Frame: This outcome measure will be assessed at 30 and 90 days from surgery ]
    mortality at 30 and 90 days from surgery

  8. patients performing the adjuvant chemotherapy. [ Time Frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled ]
    number of patients performing the adjuvant chemotherapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0.

    1. Presurgical or intraoperative stage T3-T4 N0-N+ primary tumour (TNM 8 th).
    2. Urgent presentation: perforation without purulent generalized peritonitis
    3. Positive cytology of peritoneal fluid (if previously obtained)
  2. Age ≥ 18 years and ≤75 years.
  3. Written informed consent.

Exclusion Criteria:

  1. Gastroesophageal Junction (GEJ) cancer
  2. Distant metastatic disease (even if limited and completely resected)
  3. Peritoneal carcinomatosis
  4. 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).
  5. Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
  6. Poor general conditions (ECOG > 2).
  7. 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
  8. Impaired renal function (creatinine> 1.5 upper limit of normal or creatinine clearance <60 mL / min).
  9. Impaired hepatic function (AST, ALT >2.5 upper limit of normal, bilirubin > 1.5 upper limit of normal).
  10. Impaired hematopoietic function (leucocytes <4000 / mm3, neutrophils <1500 / mm 3, platelets <100000 / mm3).
  11. Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 <50% or DLCO <40% of normal age value).
  12. 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.
  13. Pregnancy.
  14. Krukenberg tumor
  15. Refusal to join the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917173


Contacts
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Contact: Andrea Di Giorgio, MD 003906 3015 ext 7255 andrea.digiorgio@policlinicogemelli.it
Contact: Erica Rulli 0039023901 ext 4684 erica.rulli@marionegri.it

Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
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Principal Investigator: Andrea Di Giorgio Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03917173     History of Changes
Other Study ID Numbers: IRFMN-GCC-7813
2019-001478-27 ( EudraCT Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mario Negri Institute for Pharmacological Research:
gastric cancer
HIPEC CO2
Prophylactic surgery
hyperthermic intraperitoneal chemotherapy

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases