Gastric adenocarcinoma with peritoneal metastases MedDRA version: 21.1 Level: LLT Classification code 10071114 Term: Metastatic gastric adenocarcinoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Oxaliplatino
Product Code: [Oxaliplatino]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: OXALIPLATINO
CAS Number: 63121-00-6
Current Sponsor co
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age between 18-75 years • Primary gastric adenocarcinoma of first diagnosis not previously treated • Laparoscopic finding of positive peritoneal cytology and / or peritoneal localizations of disease (PCI = 6), confirmed by histological examination. • Signature of informed consent • ECOG PS scale 0-1 Patients of childbearing potential will be included in the study and monitored by serum pregnancy tests before each chemotherapy cycle and each PIPAC and at the end of treatment. Oral contraceptives will not be used due to the already high thrombotic risk related to the disease, but all other contraceptives will be used according to CTFG indications on contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: • Presence of extraperitoneal metastases; • PCI> 6; • Localization of the primary site of disease in the gastric esophagus junction of esophageal relevance (Siewert I-II); • Previous allergic reactions to cisplatin or doxorubicin; • Haemorrhagic or occlusive manifestation of disease that candidates the patient for palliative surgery; • ASA IV; • Refusal of the patient to sign the consent; • positive on diagnostic biopsies for EBV, MSI and HER2; • pregnancy and breastfeeding; • hypersensitivity to the active substances or to any of the excipients • liver failure (AST) / ALT> 3 times normal values, ALT> 3 times normal values, Bilirubin> 1.5 normal values) • Creatininemia> 1.25 mg / dL • Ischemic / haemorrhagic stroke within the past 6 months • Acute myocardial infarction within the past 6 months • Moderate / severe heart failure (NYHA III-IV) • Leukopenia <2,000 / µl • Thrombocytopenia <100,000 / µl • Active hepatitis B or C • HIV infection • creatinine clearance less than 30ml / min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether the association of PIPAC with chemotherapy compared to chemotherapy alone increases the percentage of patients who undergo surgery with radical intent (cytoreduction and HIPEC);Secondary Objective: 1. To compare overall survival in patients undergoing chemotherapy and PIPAC versus patients treated with 1st-line chemotherapy alone 2. To compare disease progression-free survival in patients receiving chemotherapy and PIPAC versus patients receiving 1st-line chemotherapy alone. 3. To compare disease-free survival in patients receiving chemotherapy and PIPAC versus patients receiving 1st-line chemotherapy alone. 4. To assess the degree of histological regression on the peritoneal biopsies in the experimental arm 5. To assess the degree of regression on the operative piece in patients undergoing radical surgery. 6. To assess the variation in quality of life before and after treatment in both groups 7. To evaluate the safety in terms of incidence, nature and severity of adverse events and abnormal laboratory values ¿¿according to CTCAE v5 classification in the two arms. 8. cost-effectiveness evaluation;Primary end point(s): Secondary Resectability Rate (%) assessed as the percentage of patients of the two arms who will go to CRS and HIPEC compared to the total number of participants at the end of the 6 or 12 chemotherapy cycles in Arm A and at the end of the 6 chemotherapy cycles and the three PIPAC in arm B;Timepoint(s) of evaluation of this end point: after 6 or 12 chemotherapy cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events assessed by CTCAE v.5; Incremental Cost-Effectiveness Ratio (ICER) per additional resectable case and per year of life gained; OS (Overall Survival); Degree of peritoneal histological response, (PRGS) For each patient of Arm B, starting from the second cycle of PIPAC, a PRGS score will be assigned for each of the four biopsies performed, associated with an average PRGS score, given by the arithmetic mean of the individual scores. Contrary to the Arm, this evaluation can only be performed at the first restadiation after three months of treatment on biopsies performed during restadiative laparoscopy or at the end of six months in those patients with stable disease who have continued chemotherapy.; Degree of histological regression on the operative piece assessed by the TRG sec. Mandard and compared between the two treatment arms in patients who will undergo cytoreduction and HIPEC; QoL assessed using the validated EORTC QLQ-C30 questionnaire, administered to the patient at the start of recruitment and after each treatment cycle or PIPAC and compared between the two treatment arms; DRS; PFS;Timepoint(s) of evaluation of this end point: after each cycle of treatment and after each PIPAC; .; after 1, 3 years; ARM B: at each biopses (starting from the second cycle of PIPAC) ARM A: at the first restadiation after three months of treatment; At surgery; at the start of recruitment and after each treatment cycle or PIPAC; 1 and 3 years; after 1, 3 years | — |
Countries
Italy
Contacts
Public ContactUOC Chirurgia Generale e dell'esofa
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed