CRITICS-II
- Conditions
- Patients with TNM 8th ed stage IB-IIC gastric adenocacinomaTherapeutic area: Diseases [C] - Neoplasms [C04]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 207
TNM 8th ed IB- IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involvegastro-oesophageal junction, Start treatment within 15 working days after randomisation, Written informed consent, Expected adequacy of follow-up, Caloric intake = 1500 kcal/day, verified by a dietician before registration. -- if caloric intake is < 1500 kcal/day or if bodyweight has decreased > 10% over the last 6 months or > 5% over the last month, dietary intervention such as oral nutritional support or enteral tube feeding is mandatory, WHO < 2, Age = 18 yrs, Resectable adenocarcinoma of the stomach or gastro-oesophageal junction, No prior abdominal radiotherapy, Haematology: Hb = 5.0 mmol/l; leukocytes = 3.0x109/l, neutrophils = 1.5x109/l, thrombocytes = 100x109/l, Renal function: serum creatinine = 1.25x ULN, creatinine clearance = 50 ml/min (calculated by Cockcroft and Gault formula), Liver function: total bilirubin = 1.5x ULN, alkaline phosphatase and ASAT/ALAT = 3x ULN, At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial freeperitoneal fluid if any should be pathologically proven tumor negative
T1N0 disease endoscopic ultrasound, 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-esophageal stent within radiation field, Distant metastases, Irresectable 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 afterconsultation 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 majorsurgery, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method