Stereotactic Body Radiotherapy for Radioresistant Bone Metastases (SOLAR-P)
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|ClinicalTrials.gov Identifier: NCT04177056|
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases Prostate Cancer Breast Cancer Renal Cell Carcinoma Melanoma||Radiation: SBRT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Body Radiotherapy for Osseous Low Alpha-Beta Resistant Metastases for Pain Relief|
|Actual Study Start Date :||December 4, 2020|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||January 1, 2023|
Experimental: Stereotactic Body Radiotherapy
High dose SBRT to lesion(s) of interest.
Patients will received a single fraction of 15-20 Gy to bone metastases causing pain. Planning and delivery will be conducted using a volumetric modulated arc therapy (VMAT) approach on the Varian TrueBeam platform. Patients will be CT simulated, with vac-lock immobilization. Use of 4-dimensional CT will be dependent on the area being treated. Daily image guidance will be performed using cone beam CT aligning to relevant bony anatomy.
- Overall Pain Response [ Time Frame: 3 months after treatment ]Assessed using the Brief Pain Inventory
- Overall Pain Response [ Time Frame: 6 months after treatment ]Assessed using the Brief Pain Inventory
- Acute Toxicity [ Time Frame: 3 months or less ]According to the Common Terminology Criteria for Adverse Events 5.0
- Late Toxicity [ Time Frame: greater than 3 months ]According to the Common Terminology Criteria for Adverse Events 5.0
- Patient-reported Quality of Life [ Time Frame: 1 month, 3 months, and 6 months ]Assessed by EORTC quality of life questionnaires
- Local Control [ Time Frame: up to 1 year ]Assessed radiographically
- Rate of Reirradiation/Salvage Surgery [ Time Frame: up to 1 year ]Due to instability or symptomatic progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177056
|Contact: Eric K Nguyen, MDfirstname.lastname@example.org|
|Juravinski Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Contact: Anand Swaminath, MD 905-387-9711 email@example.com|
|Principal Investigator:||Anand Swaminath, MD||Hamilton Health Sciences Corporation|