Plain English Summary
Study website
Contact information
Type
Public
Contact name
Ms Natasha Hava
ORCID ID
Contact details
Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
+44 20 7679 9608
ctc.abc07@ucl.ac.uk
Additional identifiers
EudraCT/CTIS number
2014-003656-31
IRAS number
ClinicalTrials.gov number
Protocol/serial number
19234
Study information
Scientific title
Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers
Acronym
ABC-07
Study hypothesis
1. The overall aim of the feasibility component of the trial is to determine if it is feasible to deliver SBRT in a multi-centre trial setting in a rare disease
2. The overall aim of the phase II trial is to evaluate the efficacy of 8 cycles of CisGem chemotherapy compared to 6 of cycles of CisGem chemotherapy followed by SBRT
Ethics approval(s)
NRES Committee London - Hampstead, 31/07/2015, ref: 15/LO/1077
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Biliary tract cancer
Intervention
Current interventions as of 19/07/2017:
All patients will be registered to receive 6 cycles of chemotherapy consisting of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Treatment takes about 2 hours each time.
Patients will then be randomised to one of two groups.
Investigational arm: Participants receive 5 or 15 fractions of SBRT over 5-21 days approximately 6 weeks after the start of cycle 6. (Number of fractions and duration of treatment depends on size of tumour on end of cycle 4 imaging).
Standard arm: Participants receive 2 further cycles of CisGem (8 cycles in total)
All patients will be followed up every 3 months for up to 2 years from date of registration.
Previous interventions:
All patients will be registered to receive 6 cycles of chemotherapy consisting of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Treatment takes about 2 hours each time.
Patients will then be randomised to one of two groups.
Investigational arm: Participants receive 5 fractions of SBRT over 5-15 days approximately 6 weeks after the start of cycle 6.
Standard arm: Participants 2 further cycles of CisGem (8 cycles in total)
All patients will be followed up every 3 months for up to 2 years from date of registration.
Intervention type
Other
Primary outcome measure
Average monthly rate of recruitment is determined over the 18 month trial period.
Secondary outcome measures
Not provided at time of registration
Overall study start date
17/07/2013
Overall study end date
30/06/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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)
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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: 83; UK Sample Size: 83
Total final enrolment
83
Participant exclusion criteria
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.
Recruitment start date
01/11/2015
Recruitment end date
03/08/2022
Locations
Countries of recruitment
England, United Kingdom, Wales
Study participating centre
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Study participating centre
University College Hospital
235 Euston Road
Fitzrovia
London
NW1 2BU
United Kingdom
Study participating centre
The Royal Marsden Hospital (Surrey)
Downs Road
Sutton
SM2 5PT
United Kingdom
Study participating centre
The Royal Marsden Hospital
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Study participating centre
Mount Vernon Cancer Centre
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Study participating centre
Lister Hospital
Chelsea Bridge Road
London
SG1 4AB
United Kingdom
Study participating centre
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
Study participating centre
Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom
Study participating centre
St Bart’s Hospital
W Smithfield
London
EC1A 7BE
United Kingdom
Study participating centre
Hammersmith Hospital
Du Cane Road
White City
London
W12 0HS
United Kingdom
Study participating centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study participating centre
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study participating centre
Queen Elizabeth Hospital
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Study participating centre
Christie Manchester
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Study participating centre
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Joint Research Office
Gower Street
London
-
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
We do not expect to make this data available to participants. The results will be published as soon as possible.
Intention to publish date
30/06/2025
Individual participant data (IPD) sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 5.0 | 06/08/2020 | 17/11/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |