EUCTR2006-000811-12-DE进行中（未招募）1 期
ST03 TrialA Randomised Phase II/III trial of Peri-operative Chemotherapy with or without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and (in selected centres) A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas - ST03
Medizinische Fakultät der Technischen Universität München0 个研究点目标入组 1,109 人开始时间: 2011年1月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,109
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with histologically verified lower oesophageal, Siewert Type I, II or III oesophagogastric junction (OGJ) adenocarcinoma or gastric adenocarcinoma, who have not received any treatment for their cancer.
- •Tumours should be Stage Ib (T1 N1, T2a/b N0), II, III or stage IV (T4 N1 or N2) with no evidence of distant metastases (M0) where the surgeon believes that an R0 resection can be achieved by excision of a contiguous structure. Patients with linitis plastica should not be randomised.
- •Tumours should be Stage II to Stage IVa (T1 N1, T2 N1, T3 N0-1, but not T2N0). T4 (N0 or N1) tumours are also eligible providing that they involve only the crura OR invade only the mediastinal pleura, where the surgeon believes that an R0 resection can be achieved by excision of a contiguous structure.
- •Patients with nodal disease affecting the origin of the left gastric and splenic artery or coeliac axis (hitherto staged as M1a) are also eligible.
- •All patients should have a CT of chest and abdomen (pelvis is optional) prior to study entry. Patients with gastric and Siewert type II and III OGJ adenocarcinomas should also have a laparoscopy prior to study entry. Endoscopic ultrasound (EUS) should be performed for all lower oesophageal and OGJ adenocarcinomas and according to local practice for other tumours.
- •The following assessments should normally be performed within 6 weeks prior to randomisation. If assessments are > 6 weeks or results are borderline please contact the ST03 Trial manager who will refer your query to the Chief Investigator.
- •- WHO performance status 0 or 1
- •- Adequate respiratory function: FEV1 > 1.5 litres (mandatory for patients with lower oesophageal and OGJ tumours only)
- •- Adequate cardiac ejection fraction (as determined by ECHO or MUGA scan) > 50% or > your centres LLN for MUGA and BP <140/90mmHg.
- •The following assessments should normally be performed within 1 week prior to randomisation and be as defined. If assessments are > 1 week or results are borderline please contact the ST03 Trial manager who will refer your query to the Chief Investigator.
- •- 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)
- •- Adequate renal function: glomerular filtration rate (GFR) >60ml/min calculated or measured. If the calculated GFR is <60ml/min then a measured GFR is required (see appendix I). The measured GFR should always take precedence over the calculated
- •- Adequate liver function
- •serum billirubin V1.5x ULN
- •ALT/AST V2.5x ULN
- •ALP V3x ULN
- •- Absence of proteinuria at baseline, defined as <2+ of protein on urine dipstick, <1g of protein/24 hr by a 24-hour urine collection or spot morning urine proteincreatinine ratio (UPCR) of <1.
- •- Adequate Coagulation profile:
- •International normalised ratio (INR) < 1.5
- •Activated ProThrombin Time (APTT) < 1.5xULN
- •- Patients on oral anticoagulation are advised to change to low molecular weight heparin prior to randomisation, to be eligible.
- •- Patients with high frequency hearing loss are eligible for ST03. They should be treated with cisplatin but changed to carboplatin if there is any evidence of deterioration
- •- Patient is fit to receive all protocol treatment
- •- Completion of baseline quality of life questionnaire
- •- Women of childbearing potential should have a negative pregnancy test within 7 days prior
排除标准
- •Cerebrovascular disease (including transient ischaemic attacks (TIA) and strokes) within 1 year before trial entry
- •Cardiovascular diseases as follows:
- •- Myocardial infarction (V 1 year prior to randomisation)
- •- Uncontrolled hypertension (defined as BP W140/90mmHg) while receiving chronic medication Patients with a BP W140/90mmHg prior to randomisation should be commenced on an ACE inhibitor or other antihypertensive agent then BP re-checked a few days later, if BP is controlled to <140/90mmHg then the patient may be entered into the trial.
- •- Angina requiring nitrate therapy within 1 year prior to randomization
- •- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •- Serious cardiac arrhythmia requiring medication (for example, ventricular tachycardia, supraventricular tachycardia or atrial fibrillation with a resting heart rate >110bpm)
- •- Major surgery, major trauma or open biopsy within 28 days prior to study entry (not including staging laparoscopy)
- •- Serious non-healing wound, ulcer or bone fracture
- •- Evidence of bleeding diathesis or coagulopathy
- •- Recent history of any active gastrointestinal inflammatory condition such as peptic ulcer disease, diverticulitis or inflammatory bowel disease. If patients have a known diagnosis of any of the above, evidence of disease control is required by negative endoscopy within the past 28 days.
- •- Patients with mild/intermittent tinnitus can be randomised to ST03 but patients with more severe tinnitus should not be randomised.
- •- Patients who have received chemotherapy or radiotherapy for a previous malignancy.
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