Study of chemotherapy in operable patients with cancer of the stomach

Phase 1

• Conditions: Gastric Cancer; MedDRA version: 20.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004500-22-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-21
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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:
a.Hematologic: absolute neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L, haemoglobin = 9.0 g/dL;
b.Hepatic: bilirubin = 1.5 times upper limits of normal (ULN), alanine transaminase (ALT) = 3 times ULN;
c.Renal: Serum creatinine =1.5 times ULN.

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the pCR rate of a new chemotherapy regimen (modified FOLFOXIRI) for operable castric cancer using sodium folinate instead of calcium folinate;Secondary Objective: <br>- To evaluate additional efficacy parameters;<br>- To evaluatesurvival relapse free survival at 1 year after surgery;<br>- To evaluate the effect of the treatment on patients' quality of life;<br>-To evaluate the safety and tolerability of the perioperative regimen.;Primary end point(s): Pathologic coplete responseafter neoadjuvant treatment;Timepoint(s) of evaluation of this end point: At the end of neoadjuvant treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ORR before surgery;<br>; Tumor regression rate; Rate of radical resection; Median relapse free survival; Evaluation of quality of life; Safety and tolerability of chemotherapy regimen (Neoadjuvant and adjuvant);Timepoint(s) of evaluation of this end point: After cycle 4 of neoadjuvant treatment; At the end of neoadjuvant treatment; At surgery; One year from surgery; At enrolment, at the end of neoadjuvant regiment, before surgery and at the end of treatment visit; From Informed consent signature to the end of treatment visit