A trial looking at whether stereotactic radiotherapy together with chemotherapy is a useful treatment for people with locally advanced bile duct cancer (ABC-07)
| ISRCTN | ISRCTN10639376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10639376 |
| EudraCT/CTIS number | 2014-003656-31 |
| Secondary identifying numbers | 19234 |
- Submission date
- 14/10/2015
- Registration date
- 14/10/2015
- Last edited
- 04/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Ms Natasha Hava
Public
Public
Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
| Phone | +44 20 7679 9608 |
|---|---|
| ctc.abc07@ucl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers |
| Study acronym | ABC-07 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/06/2024 |
Eligibility
| 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 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/11/2015 |
| Date of final enrolment | 03/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Headington
Oxford
OX3 7LE
United Kingdom
University College Hospital
235 Euston Road
Fitzrovia
London
NW1 2BU
United Kingdom
Fitzrovia
London
NW1 2BU
United Kingdom
The Royal Marsden Hospital (Surrey)
Downs Road
Sutton
SM2 5PT
United Kingdom
Sutton
SM2 5PT
United Kingdom
The Royal Marsden Hospital
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Chelsea
London
SW3 6JJ
United Kingdom
Mount Vernon Cancer Centre
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Northwood
HA6 2RN
United Kingdom
Lister Hospital
Chelsea Bridge Road
London
SG1 4AB
United Kingdom
London
SG1 4AB
United Kingdom
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
London
NW3 2QG
United Kingdom
Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom
Cardiff
CF14 2TL
United Kingdom
St Bart’s Hospital
W Smithfield
London
EC1A 7BE
United Kingdom
London
EC1A 7BE
United Kingdom
Hammersmith Hospital
Du Cane Road
White City
London
W12 0HS
United Kingdom
White City
London
W12 0HS
United Kingdom
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Southampton
SO16 6YD
United Kingdom
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Queen Elizabeth Hospital
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Birmingham
B15 2TH
United Kingdom
Christie Manchester
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Manchester
M20 4BX
United Kingdom
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Sponsor information
University College London
University/education
University/education
Joint Research Office
Gower Street
London
-
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We do not expect to make this data available to participants. The results will be published as soon as possible. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will 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 |
Additional files
Editorial Notes
04/08/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2022 to 03/08/2022.
2. The total final enrolment was added.
23/06/2022: The recruitment end date was changed from 30/06/2022 to 30/09/2022.
17/11/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/11/2021 to 30/06/2022.
2. The overall trial end date has been changed from 01/11/2023 to 30/06/2024.
3. The intention to publish date has been changed from 31/07/2017 to 30/06/2025.
4. The trial website has been added.
5. The individual participant data (IPD) sharing statement has been added.
6. The protocol (not peer reviewed) has been uploaded as an additional file.
20/09/2021: Internal review.
02/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Biliary Tract" to "Biliary tract cancer" following a request from the NIHR.
19/07/2017: Updated interventions and inclusion/exclusion criteria. Added Addenbrooke’s Hospital, Cambridge, Queen Elizabeth Hospital Birmingham, Christie, Manchester and Nottingham City Hospital as trial participating centres. Please note that the changes to the study record became effective from July 5th 2017.
09/11/2016: Verified study information with principal investigator.
19/05/2016: Plain English summary link added.
