TNM 7th ed stage IB-IIIC gastric adenocarcinoma (histologically proven)
Conditions
Interventions
Trade Name: docetaxel
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Trade Name: oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: capecitabi
Sponsors
The Netherlands Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • TNM 7th ed stage IB-IIIC gastric adenocarcinoma (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction • Performance status WHO =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: • T1N0 disease (assessed by endoscopic ultrasound) • Distant metastases • Irresectable/Iinoperable 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; in case of a previous other malignancy with a disease-free period = 5 years, inclusion can be accepted after consultation of the principal investigator • 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 arrhythmias • Continuous use of immunosuppressive agents equivalent to >10 mg daily prednison • Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine • Neurotoxicity > CTC grade 1 • Pregnancy or breast feeding • Patients (M/F) with reproductive potential not implementing adequate contraceptive measures • Gastric or gastro-oesophageal stent within radiation field
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectable gastric cancer;Secondary Objective: •To assess time to event of all treatment arms •To assess which preoperative regimen provides superior time-to-recurrence (TTR) •To assess which preoperative regimen is most feasible, based on toxicity, pCR and R0 resection rates •To assess the toxicity profile of all treatment arms •To document surgical morbidity, including incidence of anastomotic leakage •To determine the pCR rates of all treatment arms •To determine the R0 resection rates of all treatment arms •To determine the response rate (RR) of all treatment arms •To determine the OS of all treatment arms •To identify which preoperative regimen (CRITICS-II) will be compared with the new standard treatment (CRITICS-I) in a next phase III trial ;Primary end point(s): Event-free survival at 1 year after randomisation (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence, or death from any cause).;Timepoint(s) of evaluation of this end point: 1 year after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Netherlands
Contacts
Public Contactprincipal investigator
The Netherlands Cancer Institute
Outcome results
None listed