Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Miss Stana Bojanic


Contact details

Department of Neurosurgery
West Wing
John Radcliffe Hospital
Headley Way
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Protocol version 2.1, BRC Ref. A90104

Study information

Scientific title

Extra-corporeal high intensity focused ultrasound for primary sacrococcygeal bone tumours: Phase IIb trial of clinical efficacy



Study hypothesis

This study intends to study the hypothesis that high intensity focused ultrasound can be used to treat primary malignant osseous tumours of the sacrococcygeal spine in terms of reducing patients' symptoms and prolonging survival.

Ethics approval

South East Scotland Research, Ethics Committee 02, United Kingdom, Favourable Opinion 9th October 2012, Ethics reference 12/SS/0144

Study design

Non-randomised open-label non-placebo controlled Phase IIb clinical trial

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please contact to request a patient information sheet or call 01865 763100 during office hours


Primary osseous malignant bone tumours of the sacrococcygeal spine such as chordoma, osteosarcoma, etc.


The trial will take place at the Churchill Hospital, Oxford. All patients recruited must be referred from a tertiary health care doctor to be considered for the trial.
High Intensity focused ultrasound treatment (potentially staged treatment for large tumours) under general anaesthetic. After treatment, patients can expect several appointments to check on the effect of treatment using clinical examination, MRI scans, blood tests and questionnaires.

Intervention type



Phase II

Drug names

Primary outcome measure

1. To evaluate the functional outcome, pain experience and survival of patients with sacral chordomas and other primary malignant bone tumours of the sacrum treated with HIFU
2. To evaluate the effect of HIFU on radiological progression of histologically proven chordomas and other primary malignant bone tumours of the sacrum

Secondary outcome measures

1. Volume of tumour ablation on day 42 (6 weeks) on MRI imaging expressed as a percentage of pre-treatment target tumour volume
2. Number and severity of AEs / toxicity following EC-HIFU based on CTC criteria; assessed at the following points:
C3 (day 1 post-HIFU)
C4 (day 2 post-HIFU)
C5 (day 42 post-HIFU)
C6 (Day 182 post-HIFU)
C7 (Day 365 post HIFU)
3. Evidence of cavitation during EC-HIFU expressed as a ‘map’ of cavitation activity
4. Tumour volume at radiological follow-up; assessed at the following times:
C5 (6 weeks post-HIFU)
C8 (12 months post-HIFU)
5. Tumour uptake (if any) of intravenous contrast on digital-subtraction MRI imaging; assessed at the following times:
C5 (6 weeks post-HIFU)
C8 (12 months post-HIFU)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or Female, aged 18 years or above
3. Lesions must be histologically verified as primary bone tumours of the spine either by prior radiologically-guided biopsy or by histological examination of prior surgically resected samples of the tumour
4. Participant must be in sufficiently good health to be suitable for general anaesthesia for both EC-HIFU treatment (generally ASA grade 1 or 2)
5. Subjects must have ≥ 1 evaluable tumours which can be visualised on diagnostic ultrasound. If more than one tumour exists, an index tumour will be nominated and treated (uncommon)
6. Previous surgical resection and/or chemotherapy therapy for the primary bone tumour are permitted, but the subject should have recovered fully from the effects of these and the interventions should have been completed more than 12 months from the commencement
of HIFU. Previous spinal fixation as part of the procedure to remove the original tumour will not be an exclusion criterion in itself, but if at the planning stage the fixation device interferes with treatment delivery, the patient may fail pre-assessment and be excluded from the trial
7. Patients should not have received radiotherapy to the target area within the preceding 12 months
8. Subject has clinically acceptable haematological, electrolyte and hepatic function as demonstrated by serum laboratory values within 14 days prior to EC-HIFU treatment:
8.1. Absolute neutrophil count (ANC) ≥ 1500mm-3
8.2. Platelet count ≥ 100,000mm-3
8.3. Haemoglobin ≥ 10gdl-1
8.4. Prothrombin time (PT) ≤ 1.5 * Upper Limit of Normal (ULN)
8.5. Activated partial thomboplastin time (APTT) ≤ 1.5 * ULN
8.6. Total bilirubin < 2.5 * ULN
8.7. Aspartate aminotransferase (AST) < 3 * ULN
8.8. Alkaline phosphatase (ALP) < 2 * ULN; unless arising from bone
9. Participants have a clinically acceptable ECG
10. Negative pregnancy test within 24 hours of EC-HIFU treatment (if appropriate)
11. Able (in the Investigators opinion) and willing to comply with all study requirements
12. Willing to allow his or her General Practitioner and referring Consultant, if appropriate, to be notified of participation in the study, and be contacted 5 years after treatment to assess survival
13. A World Health Organisation (WHO) performance status of ≤ 1

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Female participants who are pregnant, lactating or planning pregnancy during the course of the study (see pregnancy test note above)
2. Significant hepatic impairment
3. Significant renal impairment
4. Scheduled elective surgery or other procedures requiring general anaesthesia within a period of 8 weeks after finishing HIFU treatment
5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
6. Participants currently involved in any medicinal trial
7. Participants involved in the treatment phase of a clinical trial (observational or follow-up studies will be allowed)
8. If, during the planning stage, it is adjudged by the planning team that treatment to the tumour may pose an unacceptable risk to the patient’s life or health, for example if a segment of bowel is likely to be damaged by the HIFU beam, the patient will be excluded. In this circumstance the patient’s intention to participate in the trial will be recorded in the CRF and the technical reason for exclusion recorded. Patients excluded from the trial for technical reasons will be reported in future analyses to help scrutinising clinicians decide
on the viability of HIFU as a treatment.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Neurosurgery
United Kingdom

Sponsor information


Oxford University Hospitals NHS trust (UK)

Sponsor details

c/o Martin Gillies
Department of Neurosurgery
West Wing
John Radcliffe Hospital
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research Oxford Biomedical Research Centre (UK) , Ref. A90104

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes