A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer (CRITICS-study: ChemoRadiotherapy after Induction chemoTherapy In Cancer of the Stomach).
- Conditions
- gastric carcinoma1001799010017991gastric cancer
- Registration Number
- NL-OMON50400
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
• Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor
bulk has to be in the stomach but may involve gastro-esophageal junction
• WHO < 2
• age >=18 yrs
• Operable gastric cancer
• No prior abdominal radiotherapy or chemotherapy
• Hematology: Hb >= 5.0 mmol/l; leukocytes >= 3.0x109/l, neutrophils >= 1.5x109/l,
thrombocytes >= 100 x 109/l
• 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
• Total bilirubin <=1.5x ULN, Alkaline phosphatase and ASAT/ALAT <= 3x ULN
• Left ventricular ejection fraction > 50%
• Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis
• Start treatment within 10 working days after registration
• Written informed consent
• T1N0 disease (endoscopic ultrasound)
• Distant metastases
• Inoperable patients
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Disease free survival<br /><br>Genomic prophyling and proteomics<br /><br>Quality of life<br /><br>Toxicity (NCI-CTC, version 3.0).</p><br>