Palliative radiation is effective for controlling or preventing symptoms such as pain, bleeding, dyspnea, and cord compression. Recently, studies have shown that additional dose escalation may result in superior local control. The investigators propose a phase II single arm trial to evaluate a novel high-dose radiation regimen, which will be 27 Gray in 3 fractions with dose escalation within the tumour (Hi-D).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
5.1. Inclusion Criteria
Subjects must meet all of the following criteria to be eligible for participation in this study:
* Age 18 or older.
* Able to provide informed consent
* Patient has histologically confirmed solid tumour malignancy
* ECOG performance status 0 - 2
* Life Expectancy \> 6 months
* Locally advanced or metastatic disease with 1-3 target lesions larger than 5cm in minimum dimension, with no more than 2 target lesions in a single organ; patients can have any number of non-target lesions
* A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment
* Not suitable for or declined curative-intent treatment
* Subject has had a CT chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and with 12 weeks of treatment
* MRI spine for patients receiving RT to vertebral or paraspinal metastases
* Patient is judged able to:
* Maintain a stable position during therapy
* Tolerate immobilization device(s) that may be required to deliver radiation safely
5.2. Exclusion Criteria
Subjects are excluded from the study if any of the following criteria apply:
* Hematologic malignancy
* Disease limited to intracranial sites
* Serious medical co-morbidities precluding radiotherapy
* Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs.
* Pregnant people
Primary outcome measure(s)
Local Control — 4 years, with 2 years of accrual and 2 years of follow up to determine the length of time from treatment to tumor growth, recurrence, or progression at radiated sites achieved when using high-dose palliative radiotherapy
Trial sites (1)
Facility
City
Region
Status
BC Cancer - Vancouver
Vancouver
British Columbia
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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