multicentric randomised trial for resectable gastric cancer

Conditions: Gastric Cancer

Summary: the critics-ii trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. the rationale behind this trial design is based on the following concepts: * preoperative treatment is associated with better patient compliance than postoperative regimens * preoperative treatment increases the likelihood of disease downsizing/downstaging and radical r0 resections * preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and doc chemotherapy are effective, feasible and safe regimens


Eligibility criteria:
inclusion criteria: * tnm 8th ed stage ib-iiic gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction * 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 free peritoneal fluid if any should be pathologically proven tumor negative * written informed consent * expected adequacy of follow-up * caloric intake≥1500 kcal/day, verified by a dietician before registration. * if caloric intake is \ 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 exclusion criteria: * t1n0 disease (assessed by 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; 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-esophageal stent within radiation field

Keywords: gastric cancer radiotherapy chemoradiotherapy