A trial looking at whether stereotactic radiotherapy together with chemotherapy is a useful treatment for people with locally advanced bile duct cancer (ABC-07)
- Conditions
- Biliary tract cancerCancerMalignant neoplasm of other and unspecified parts of biliary tract
- Registration Number
- ISRCTN10639376
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 83
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average monthly rate of recruitment is determined over the 18 month trial period.
- Secondary Outcome Measures
Name Time Method ot provided at time of registration