Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04177056 |
| Other study ID # |
7905 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 4, 2020 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
July 2021 |
| Source |
Hamilton Health Sciences Corporation |
| Contact |
Stephan Tran, MD |
| Phone |
905-387-9711 |
| Email |
transt[@]hhsc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Radiation therapy has been shown to be very effective at relieving pain caused by bone
metastases. However, certain types of cancers such as prostate, breast, kidney, and melanoma
can have resistance to radiation, making treatment less successful. Stereotactic body
radiotherapy (SBRT) is a newer form of focused treatment that gives higher doses of radiation
without damage to surrounding organs. It often is used to help control and cure disease, but
less commonly as a way to palliate and treat symptoms. This study is looking at using SBRT
for the purposes of improving pain caused by bone metastases in prostate cancer, breast
cancer, kidney cancer, and melanoma patients. It is theorized that the higher levels of
radiation may be able to combat the resistance some tumour cells have to radiotherapy and
provide improved pain response to treatment. The investigators are looking to show that SBRT
has a role in helping this group of patients deal with painful bone lesions from their cancer
without increasing side effects and toxicity from the radiation treatment.
Description:
Stereotactic body radiotherapy (SBRT) has shown promising early results in the management of
bone metastases. However, there is a paucity of prospective data studying the use of SBRT for
bone metastases originating from low alpha-beta tumors, with systematic reporting of changes
in pain scores and analgesia use over time. The vast majority data looking at SBRT in bone
lesions focuses on local control and survival, rather than more tangible outcomes in a
palliative population including symptomatic control, durability of response, and patient
reported quality of life; a component that is understudied in this group despite its
tremendous value. Furthermore, SBRT for bone metastases has yet to become common practice
given the limited evidence for its efficacy and uncertainty in regards to toxicity.
The current study proposes an investigation of the potential benefits of SBRT for symptomatic
bone metastases in patients with prostate cancer, breast cancer, renal cell carcinoma,
melanoma, and sarcoma. The investigators look to conduct a prospective cohort study that is
adequately powered to analyse efficacy in alleviating pain from bone lesions and compare this
to well-established rates in literature for conventionally fractionated palliative RT.
Furthermore, this study will assess the tolerability of this modality, toxicity rates, and
effect on quality of life. If the results show that SBRT has a significant benefit on this
population, the goal would be to pursue a larger randomized trial to confirm the findings.
