Condition category
Cancer
Date applied
14/10/2015
Date assigned
14/10/2015
Last edited
09/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

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 number

2014-003656-31

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

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

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Biliary Tract

Intervention

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 rone 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

Phase

Drug names

Primary outcome measures

Average monthly rate of recruitment is determined over the 18 month trial period.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/07/2013

Overall trial end date

01/11/2023

Reason abandoned

Eligibility

Participant 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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 83; UK Sample Size: 83

Participant 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

01/11/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Churchill Hospital
Old Road Headington
Oxford
OX3 7LE
United Kingdom

Trial participating centre

University College Hospital
235 Euston Road Fitzrovia
London
NW1 2BU
United Kingdom

Trial participating centre

The Royal Marsden Hospital (Surrey)
Downs Road
Sutton
SM2 5PT
United Kingdom

Trial participating centre

The Royal Marsden Hospital
Fulham Road Chelsea
London
SW3 6JJ
United Kingdom

Trial participating centre

Mount Vernon Cancer Centre
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Trial participating centre

Lister Hospital
Chelsea Bridge Road
London
SG1 4AB
United Kingdom

Trial participating centre

Royal free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom

Trial participating centre

St Bart’s Hospital
W Smithfield
London
EC1A 7BE
United Kingdom

Trial participating centre

Hammersmith Hospital
Du Cane Road White City
London
W12 0HS
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
Gower Street
London
v
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

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.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/11/2016: Verified study information with principal investigator. 19/05/2016: Plain English summary link added.