EUCTR2015-004627-31-NL
Active, not recruiting
Phase 1
A multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery vs. neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery vs. neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer - CRITICS-II
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Netherlands Cancer Institute
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 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
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
Outcomes
Primary Outcomes
Not specified
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