Addition of stereotactic body radiotherapy (SBRT) to chemotherapy in locally advanced biliary tract cancers

Phase 1

• Conditions: ocally advanced biliary tract cancer; MedDRA version: 21.0Level: LLTClassification code 10004586Term: Bile duct adenocarcinoma non-resectableSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003656-31-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-04
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. A histopathological/cytological diagnosis of locally advanced, non-resectable biliary tract carcinoma (intra- or extra-hepatic), (excluding cancer of the gall bladder and ampullary carcinoma)
2. Not suitable for radical surgery, or medically unfit for surgery as decided by a hepatobiliary MDT
3. Tumour visible on cross-sectional imaging
4. Measurable disease (according to RECIST criteria v1.1). (If disease is not measurable using RECIST v1.1, the tumour must be visible for targeting with radiation).
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 PS 0 or 1
8. Adequate haematological function:
• Haemoglobin = 100 g/L (the use of transfusion to achieve desired Hb is acceptable)
• White blood cell count (WBC) = 3.0 x 109/L
• Absolute neutrophil count (ANC) =1.5 x 109/L
• Platelet count = 100 x 109/L
9. Adequate liver function:
• Total bilirubin =3.0 x ULN. Total bilirubin levels must be considered stable by the treating clinician e.g. more than one reading is required to show they are stable. Exceptions are possible for patients with known documented cases of Gilbert’s syndrome, as long as the Bilirubin is stable and the treating clinician feels that the increased bilirubin is not due to obstruction or cholangitis.
• ALT and/or AST = 2.5 x ULN
• ALP = 5 x ULN
• Albumin > 25 g/L
10. Adequate renal function:
• Serum urea < 1.5 x ULN
• Serum creatinine < 1.5 x ULN
• GFR = 45 mL/min using a validated creatinine clearance calculation (e.g. Cockroft-Gault 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. Alternatively, if calculated GFR is <45mL/min, a protein/creatinine ratio can be used in 24 hours collected urine to confirm GFR = 45 mL/min .
11. Life expectancy >12 weeks
12. 16 years of age 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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)
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.Patients who have a concurrent malignancy that is clinically unstable and requires tumour-directed treatment are not eligible. Exceptions include low grade malignancies that do not require active treatment, such as early prostate cancer under surveillance or chronic lymphocytic leukaemia.
7. History of prior malignancy that could interfere with the response evaluation or survival. Exceptions include:
•in-situ carcinoma of the cervix treated by cone-biopsy/resection,
•non-metastatic basal and/or squamous cell carcinomas of the skin,
•any early stage malignancy diagnosed over two years ago and radically treated.
7
8. Other concomitant anti-cancer therapy (except steroids)
9. Any psychiatric or other disorder likely to impact on informed consent.
10. Women who are pregnant or breast feeding

NB. Whilst not 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 clinical trial of medicinal product
• Study Design: Not specified