ISRCTN10639376进行中（未招募）未知
Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers
niversity College London0 个研究点目标入组 83 人开始时间: 2015年10月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 83
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 19/07/2017:
- •1. A histopathological/cytological diagnosis of locally advanced, non-resectable biliary tract carcinoma (intra or extrahepatic), or ampullary carcinoma
- •2. Not suitable for radical surgery, or medically unfit for surgery as decided by a hepatobiliary MDT
- •3. Tumour visible on crosssectional imaging
- •4. Measurable disease (according to RECIST criteria v1.1) (If disease is not measurable using RECIST v1.1, due to location in the vicinity of the hilum, the tumour must be visible for targeting with radiation using other multimodality imaging such as ERCP, MRCP)
- •5. Tumour (and nodes if involved) must be =12 cm in the longest dimension. For patients with non-measurable disease, sites should use the CT reconstructions (coronal or sagittal views) to measure tumour size.
- •6. Adequate biliary drainage
- •7. WHO performance status (PS) 0 or 1
- •8. Adequate haematological function:
- •8.1. Haemoglobin = 100 g/L (the use of transfusion to achieve desired Hb is acceptable)
- •8.2. White blood cell count (WBC) = 3.0 x 109/L
- •8.3. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •8.4. Platelet count = 100 x 109/L
- •9. Adequate liver function:
- •9.1. Total bilirubin = 1.5 x ULN (except for patients with known documented cases of Gilbert’s syndrome)
- •9.2. ALT and/or AST = 2.5 x ULN
- •9.3. ALP = 5 x ULN
- •9.4. Albumin >25g/L
- •10. Adequate renal function:
- •10.1. Serum urea < 1.5 x ULN
- •10.2. Serum creatinine < 1.5 x ULN
- •10.3. GFR = 45 mL/min using a validated creatinine clearance calculation (e.g. CockroftGault or Wright formula). If the calculated creatinine clearance is less than 45 mL/min, GFR should be assessed using an isotopic clearance method to confirm GFR = 45 mL/min
- •11. Life expectancy of more than 12 weeks
- •12. Aged 16 years or over
- •13. Patients may have had prior chemotherapy as long as patient meets all other inclusion/exclusion criteria
- •14. Patient must have given written informed consent
- •Previously inclusion criteria:
- •1. A histopathological/cytological diagnosis of locally advanced, non-resectable biliary tract carcinoma (intra or extrahepatic), or ampullary carcinoma
- •2. Not suitable for radical surgery, or medically unfit for surgery as decided by a hepatobiliary MDT
- •3. Tumour visible on crosssectional imaging
- •4. Measurable disease (according to RECIST criteria v1.1)
- •5. Tumour must be = 6 cm in the longest dimension
- •6. Adequate biliary drainage
- •7. WHO performance status (PS) 0 or 1
- •8. Adequate haematological function:
- •8.1. Haemoglobin = 100 g/L (the use of transfusion to achieve desired Hb is acceptable)
- •8.2. White blood cell count (WBC) = 3.0 x 109/L
- •8.3. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •8.4. Platelet count = 100 x 109/L
- •9. Adequate liver function:
- •9.1. Total bilirubin = 1.5 x ULN (except for patients with known documented cases of Gilbert’s syndrome)
排除标准
- •Current exclusion criteria as of 19/07/2017:
- •1. Metastatic disease
- •2. Direct tumour extension in the duodenum, stomach, small bowel or large bowel.
- •3. Previous abdominal radiotherapy or previous selective internal radiotherapy such as hepatic arterial Yttrium therapy
- •4. Previous hypersensitivity to platinum salts
- •5. Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (including diabetes with established sensory peripheral neuropathy, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •6. History of prior malignancy that could interfere with the response evaluation or survival. (Exceptions include: insitu carcinoma of the cervix treated by conebiopsy/resection, nonmetastatic basal and/or squamous cell carcinomas of the skin, or any early stage malignancy radically treated in the last two years, early prostate cancer under surveillance.
- •7. Other concomitant anticancer therapy (except steroids)
- •8. Any psychiatric or other disorder likely to impact on informed consent.
- •9. Women who are pregnant or lactating
- •10. Whilst not specifically excluded, patients with significant hearing impairment must be made aware of potential ototoxicity and may choose not to be included. If included, it is recommended that audiograms be carried out at baseline and prior cycle 2 of CisGem.
- •Previous exclusion criteria:
- •1. Metastatic disease
- •2. Direct tumour extension in the duodenum, stomach, small bowel or large bowel.
- •3. Previous abdominal radiotherapy or previous selective internal radiotherapy such as hepatic arterial Yttrium therapy
- •4. Previous hypersensitivity to platinum salts
- •5. Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (including diabetes with established sensory peripheral neuropathy, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •6. History of prior malignancy that could interfere with the response evaluation (exceptions include insitu carcinoma of the cervix treated by conebiopsy/resection, nonmetastatic basal and/or squamous cell carcinomas of the skin, or any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously)
- •7. Other concomitant anticancer therapy (except steroids)
- •8. Any psychiatric or other disorder likely to impact on informed consent.
- •9. Women who are pregnant or lactating
- •10. Whilst not specifically excluded, patients with significant hearing impairment must be made aware of potential ototoxicity and may choose not to be included. If included, it is recommended that audiograms be carried out at baseline and prior cycle 2 of CisGem.
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