RecruitingPhase 2ACTRN12615001031550

Radiation treatment prior to surgery for local spine metastasis

A Phase II Study for the Treatment of Localised Spine Metastasis: Assessing the Safety and Efficacy of Image Guided Radiosurgery prior to Surgical Stabilisation.


Sponsor

Epworth HealthCare

Enrollment

20 participants

Start Date

Jul 3, 2017

Study Type

Interventional

Conditions

Summary

The primary purpose of this study is to determine whether Stereotactic Body Radiotherapy (SBRT) given prior to surgery is technically feasible and clinically safe for the treatment of patients with localised spine metastases. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years, have any non-haematological cancer type, and have been diagnosed with spinal metastases in the past 4 weeks for which spinal surgery has been prescribed. Study details: SBRT is a type of radiation therapy in which a few, very high, doses of radiation are very accurately delivered to a small, well-defined target area. It is normally delivered after surgery in the treatment of spinal metastases however this approach has a number of drawbacks. In this study, all participants will receive radiation treatment at least 7 days before surgery, with doses ranging between 16 – 24 Gy over 1-2 days. Patients will be assessed for signs of toxicity and pain at 1 then 3 monthly intervals for 2 years following the SBRT treatment. It is hoped that the findings of this trial will aid understanding of whether it is technically possible, and safe, to deliver SBRT prior to surgery for spinal metastases, in place of the current standard care in which SBRT is delivered following surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a type of precise, high-dose radiation treatment (Stereotactic Body Radiotherapy, or SBRT) before surgery — rather than after — is safe and practical for people who have cancer that has spread to the spine. Usually, radiation is given after spine surgery. Doing it before may make the surgery more effective by shrinking the tumour first. You may be eligible if: - You are between 18 and 85 years old - You have a non-blood cancer that has spread to the spine (C1–L5) - You have been recommended for spinal surgery based on recent imaging - Your cancer functional score (Tokuhashi) is 9 or above - Your physical performance score (Karnofsky) is above 70% - No more than two connected spinal levels are involved You may NOT be eligible if: - You have rapidly worsening neurological symptoms - You have already had radiation to the same spinal level - You are not able to walk at all - You have had recent chemotherapy (within 3 weeks) - You are pregnant Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will undergo stereotactic body radiotherapy (SBRT) within 36 hours of being consented for the study. Participants will proceed to spinal surgery at least 7 days following the last SBRT tr

Participants will undergo stereotactic body radiotherapy (SBRT) within 36 hours of being consented for the study. Participants will proceed to spinal surgery at least 7 days following the last SBRT treatment fraction. Participants will receive either: 1) 16 Gy in a single fraction (radiosensitive histology); 2) 18 Gy in a single fraction (radioresistant histology); or 3) 24 Gy in two fractions, at one fraction per day, over two consecutive days in the same week (Mon to Fri) when spinal cord constraints cannot be met for 16 or 18 Gy plans. The dose prescription and fractionation will be decided by the referring radiation oncologist based on cancer histology, tumour location and other factors. All treatments will be planned off a single simulation CT scan, and treatment will be delivered using daily kV orthogonal imaging with 6D correction and cone-beam computed tomography. Participant adherence will be monitored through the departmental record and verify system.


Locations(2)

Epworth Richmond - Richmond

VIC, Australia

Epworth Freemasons - Melbourne

VIC, Australia

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ACTRN12615001031550