Resectable gastric cancer MedDRA version: 8.1 Level: LLT Classification code 10017758 Term: Gastric cancer
Conditions
Interventions
Trade Name: Xeloda
Pharmaceutical Form: Tablet
Trade Name: Cisplatin
Product Name: cisplatin
Product Code: n.a.
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15
Sponsors
NKI/Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk has to be in the stomach but may involve gastro-esophageal junction • WHO 5.0 mmol/l; leukocytes > 3.0x109/l, neutrophils > 1.5x109/l, thrombocytes > 100 x 109/l • Renal function: serum creatinine = 1.25 ULN, creatinine clearance > 60 ml/min (measured, or calculated by Cockcroft and Gault formula) and urinary excretion of = 1.0 gram protein/24 hours • Liver function: total bilirubin =1.5x ULN, Alkaline phosphatase and ASAT/ALAT = 3x ULN • Left ventricular ejection fraction > 50% • Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis • Written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • T1N0 disease (endoscopic ultrasound) • Distant metastases • Inoperable patients; due to technical surgery-related factors or general condition • Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri. • Solitary functioning kidney that will be within the radiation field • Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery • Uncontrolled (bacterial) infections • Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments • Uncontrolled angina pectoris; cardiac failure or clinically significant arrhytmias • Continuous use of immunosuppressive agents • Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine • Hearing loss > CTC grade 1 • Neurotoxicity > CTC grade 1 • Pregnancy or breast feeding • Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether postoperative chemoradiotherapy prolongs overall survival compared to postoperative chemotherapy in patients that have had adequate stomach surgery following preoperative chemotherapy;Secondary Objective: To assess whether postoperative chemoradiotherapy prolongs disease free survival compared to postoperative chemotherapy in patients that have had adequate stomach surgery following preoperative chemotherapy To collect tissue and serum before treatment for genomic profiling and proteomics to detect tumor recurrence risk patterns in gastric cancer To determine a genomic profile and classifier to predict response to therapy To assess the value of Maruyama-index and predictive nomograms for disease recurrence (36;37) To compare health-related quality of life (HRQL) of both treatment regimens;Primary end point(s): Overall survival | — |
Countries
Denmark, Netherlands, Sweden
Outcome results
None listed