Clinical trial NCT04177056: Stereotactic Body Radiotherapy for Osseous Low Alpha-Beta Resistant Metastases for Pain Relief
Official title: Stereotactic Body Radiotherapy for Osseous Low Alpha-Beta Resistant Metastases for Pain Relief
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Metastases
Prostate Cancer
Breast Cancer
Renal Cell Carcinoma
Melanoma
Keywords: SOLAR-P
SBRT
Bone metastases
stereotactic
pain relief
quality of life
palliation
low alpha beta
radioresistant
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Juravinski Cancer Centre Foundation
First posted: 2019-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of prostate cancer, renal cell carcinoma, or melanoma
* Radiographic evidence of bone metastases requiring treatment for pain
* Brief Pain Inventory score of ≥ 2

Exclusion Criteria:

* Spinal lesions
* Severe or progressive neurological deficit
* Impending or existing pathological fracture
* Bone metastasis in a previously irradiated site
* Active systemic therapy
* \>5 lesions requiring treatment
* Lesions \>5 cm in largest diameter
* Life expectancy \< 3 months
* Age \< 18
* Karnofsky Performance Status \< 50
* Unable to provide informed consent

Primary outcomes:
measure: Overall Pain Response
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Overall Pain Response
timeFrame: 6 months after treatment
measure: Acute Toxicity
timeFrame: 3 months or less
measure: Late Toxicity
timeFrame: greater than 3 months
measure: Patient-reported Quality of Life
timeFrame: 1 month, 3 months, and 6 months
measure: Local Control
timeFrame: up to 1 year
measure: Rate of Reirradiation/Salvage Surgery
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Anand Swaminath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen EK, Quan K, Parpia S, Tran S, Swaminath A. Stereotactic body radiotherapy for osseous low alpha-beta resistant metastases for pain relief-SOLAR-P. Radiat Oncol. 2021 Sep 3;16(1):170. doi: 10.1186/s13014-021-01897-0.