NL-OMON53113
Recruiting
Phase 2
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
Antoni van Leeuwenhoek Ziekenhuis0 sites207 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- stomach cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 207
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •TNM 8th ed IB\- IIIC gastric cancer (histologically proven); tumour bulk has
- •to be in the stomach but may involve gastro\-oesophageal junction
- •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
Exclusion Criteria
- •T1N0 disease endoscopic ultrasound
- •Distant metastases
- •Irresectable patients; due to technical surgery\-related factors or general
- •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
Outcomes
Primary Outcomes
Not specified
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