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Researchers at Oxford University Hospitals are recruiting sacral chordoma patients for a clinical trial using High Intensity Focused Ultrasound (HIFU).

Trial: EXTRA-CORPOREAL HIGH INTENSITY FOCUSED ULTRASOUND FOR PRIMARY SACROCOCCYGEAL BONE TUMOURS:

PHASE IIb TRIAL OF CLINICAL EFFICACY

Study question: Can HIFU reduce tumour burden (defined radiologically) in patients with low grade malignant bone tumours of the sacrum and coccyx, leading to improvements in 5 year survival and symptom control?

Rationale: Low grade malignant tumours of the sacrum (primarily chordoma, osteosarcoma) are difficult to treat owing to their relative radio resistance and high morbidity associated with surgical resection. High intensity focused ultrasound (HIFU) is a technique using high energy sound waves to cause cell death in tissues, that can cause cell death irrespective of the mitotic rate of the tissue through cavitation and heating of individual cells. HIFU has had success in treating several forms of solid tumours (e.g. fibroids and prostate cancer) non-invasively. We have trialled HIFU on 3 patients with recurrent sacral chordoma who experienced radiological reduction in tumour size associated with improvement in pain symptoms. We wish to test formally if HIFU has a role in the treatment of sacral chordomas and osteosarcomas.

Trial participants: We aim to recruit at least 14 patients from across the UK with sacral chordoma or osteosarcoma. The trial is open to patients who have had previous surgery (including spinal fixation) and/or radiotherapy. Patients must be over 18 yrs old and able to give informed consent. We have money available to help with the patients’ travel costs.

Exclusion criteria: Primarily patients who are unfit for day case general anaesthesia, pregnant (or planning to be pregnant during the treatment phase of the trial) and patients in whom the tumour cannot be visualised on B mode ultrasound, or safely treated because of the interposition of a hollow viscus in the path of the HIFU beam, shall be excluded from the trial.

Primary outcomes: 5 yr survival, pain scores, quality of life indices.

Recruitment is now open.

For further information, please email: martin.gillies@ouh.nhs.uk

To refer a patient please send a clinic letter and up to date (within 3 months) MRI pelvis with contrast on CD to

Miss Stana Bojanic . Dept of Neurosurgery

West Wing

John Radcliffe Hospital

Oxford

OX3 9DU

All treatment will take place at the Churchill Hospital, Oxford UK.


 



 

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