Patient with potentially resectable adenocarcinoma of the stomach MedDRA version: 14.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
Concentration unit: mg/m2 milligram(s)/square meter
Concentration number: 35-
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female 18-75 years of age • Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach • cT3 subserosal - cT4a – cT4b (7th edition UICC TNM) or bulky lymph node metastases independently of T • ECOG performance status 0-1 at study entry • Laboratory requirements (up to 8 days prior to randomization): a) Haematology: I) Neutrophils > 1.5 x 109 /L II) Platelets > 100 x 109 /L III) Hemoglobin > 10g/dL b) Hepatic function I) Total bilirubin = 60 mL/min; • Written informed consent signed and dated before randomization procedures, must be obtained and documented according to the local regulatory requirement. • Effective contraception for both male and female patients if the risk of conception exists. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Early gastric cancer (if N0) • T2 (according to 7th edition of UICC TNM) if N0 • Linitis plastica • Positive peritoneal cytology • Distant metastases • Tumor involving the gastro-esophageal junction • Peritoneal involvement • Concurrent chronic systemic immune therapy • Any investigational agent(s) 4 weeks prior to study entry • Clinically relevant coronary artery disease, a history of myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months • Known grade 3 or 4 allergic reaction to any of the components of the treatment • Known drug abuse/alcohol abuse • Legal incapacity or limited legal capacity • Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent • Women who are pregnant or breastfeeding • Acute or subacute intestinal occlusion • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for = 5 years will be allowed to enter the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The percentage of patients receiving all the planned chemotherapeutic cycles.;Secondary Objective: • Downstaging according to Recist criteria • pT1-3 vs pT0. • Safety: number of patients with grade 3-4 toxicity • The role of PET Scan as predictor of response • Curative vs palliative surgery • TTP • OS • Diagnostic correlation between the various staging methods • Possible correlations between CT scan, CT/PET, laparoscopy; • Molecualr marker related to toxicity: DPYD, MTHFR, TS, XPD, ERCC1, XRCC1; • Molecular marker related to prognosis: TYMS, GSTP1, COX-2, RUNX3, methylation profile (Cox2, hMLH1, MGMT); • Molecular marker related to therapy response: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, methylation profile (Cox2, hMLH1, MGMT), whole genome arrayCGH;Primary end point(s): The percentage of patients receiving all the planned chemotherapeutic cycles. | — |
Countries
Italy
Outcome results
None listed