ISRCTN60280514已完成3 期
eo-AEGIS (NEO-adjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study): Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (Investigator’s choice of Modified MAGIC or FLOT regimen) versus neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 377
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37734399/ (added 15/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically verified adenocarcinoma of the oesophagus or oesophagogastric junction based on OGD
- •2. CT- 18FDG-PET in all patients and EUS, if feasible
- •3. Staging laparoscopy will be performed for tumours of the abdominal oesophagus, junction and
- •proximal stomach i.e. AEG II and AEG III (at the investigator's discretion)
- •4. Pre-treatment stage cT2-3, N0-3, M0
- •5. No prior abdominal or thoracic radiotherapy
- •6. Male/female patients aged >18 years
- •7. ECOG Performance Status 0, 1 or 2
- •8. ASA Grading I-II
- •9. Adequate cardiac function. For patients with a significant cardiac history (e.g. known ischaemic disease, cardiomyopathy) an ejection fraction >50% and cardiac clearance
- •by a consultant cardiologist for major surgery and cancer therapies is required, if clinically indicated.
- •Where necessary, the Chief Investigator should be consulted to discuss the patient's eligibility.
- •10. Adequate respiratory function. Patients should have pulmonary function tests completed with FEV1 >1.5L
- •11.Adequate bone marrow function: absolute neutrophil count (ANC) >1.5x109/l; white blood cell count >3x109/l; platelets >
- •100x109/l; haemoglobin (Hb) >9g/dl (can be post-transfusion).
- •12.Adequate renal function: glomerular filtration rate >60ml/minute calculated using the Cockcroft-Gault Formula
- •13.Adequate liver function: serum bilirubin <1.5x ULN; AST <2.5x ULN and ALP <3x ULN (ULN as per institutional standard)
- •14. Written informed consent must be obtained from the patient before any study specific procedures are performed
排除标准
- •1. Tumours of squamous histology
- •2. Patients with advanced inoperable or metastatic oesophageal, junctional or gastric adenocarcinoma
- •3. Any prior chemotherapy for gastrointestinal cancer
- •4. Prior abdominal or thoracic radiation
- •5. Patients who are unfit for surgery or cancer treatments based on cardiac disease
- •6. Clinical COPD with significant obstructive airways disease classified by FEV1 < 1.5 L or PaO2 less than 9kPa on room air
- •7. Known peripheral neuropathy >Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
- •8. Known positive tests for human immunodeficiency virus (HIV) infection, acute or chronic active hepatitis B infection
- •9. Any other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
研究者
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已完成
3 期
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