Phase II multicentre trial of perioperative chemotherapy in operable patients with gastric cancer (PERISCOPE trial) - Ph II CT of perioperative chemotherapy in operable patients with gastric cancer

GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)0 sites65 target enrollmentMarch 21, 2018

Overview

No summary available.

Registry

who.int

Start Date

March 21, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)

•1\.Males or females \= 18 years old;
•2\.Written, signed consent for trial participation;
•3\.Patients should consent to optional provision of a sample of blood (30 ml) and urine (10 ml) at basal time and every month during neoadjuvant, before surgery, one month after surgery, at the end of adjuvant treatment and every 4 months during follow\-up (in order that specific correlative marker assays could be performed);
•4\.Patients should also consent to optional provision of available histological tissue (e.g. bioptic and surgical tissue) in order that correlative marker assays could be performed;
•5\.Histological or cytological diagnosis of GC;
•6\.Clinical staging of GC cT2\-4/cN\-any/cM0 or cT\-any/cN\+/cM0 (according to the 8th edition of the UICC TNM classification performed with thoraco\-abdominal CT scan, ecoendoscopy and esophagogastroduodenoscopy performed within 4 weeks prior to randomization;
•7\.No prior treatments (chemo or radiotherapy);
•8\.Measurable disease, defined in accordance with RECIST (Response Evaluation Criteria in Solid Tumors) criteria version 1\.1, evaluated with ecoendoscopy, esophagogastroduodenoscopy and thoraco\-abdominal CT scan;
•9\.Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
•10\.Adequate organ function assessed within 4 weeks prior to randomization including:

•1\.ECOG PS \> 1;
•2\.Metastatic Gastric Cancer;
•3\.Previous chemo or radiotherapy;
•4\.Current active infection;
•5\.Serious pre\-existing medical conditions or serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris, or a clinically significant history of cardiac disease or renal disease, neurological disease or condition of peripheral neuropathy);
•6\.Females who are pregnant or lactating;
•7\.Patients with a history of other malignancies except: adequately treated non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \> 3 years;
•8\.Patients unable to undergo medical test for geographical, social or psychological reason;
•9\.Known dihydropyrimidine dehydrogenase (DPD) deficiency.