SOLAR-P: Stereotactic Body Radiotherapy for Osseous Low Alpha-Beta Resistant Metastases for Pain Relief

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Recruiting

CT.gov ID

NCT04177056

Collaborator

Juravinski Cancer Centre Foundation (Other)

Enrollment

Location

Arm

24.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Metastases Prostate Cancer Breast Cancer Renal Cell Carcinoma Melanoma	Radiation: SBRT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stereotactic Body Radiotherapy for Osseous Low Alpha-Beta Resistant Metastases for Pain Relief

Actual Study Start Date :

Dec 4, 2020

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stereotactic Body Radiotherapy High dose SBRT to lesion(s) of interest.	Radiation: SBRT 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.

Arm

Intervention/Treatment

Experimental: Stereotactic Body Radiotherapy

High dose SBRT to lesion(s) of interest.

Radiation: SBRT

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.

Outcome Measures

Primary Outcome Measures

Overall Pain Response [3 months after treatment]
Assessed using the Brief Pain Inventory

Secondary Outcome Measures

Overall Pain Response [6 months after treatment]
Assessed using the Brief Pain Inventory
Acute Toxicity [3 months or less]
According to the Common Terminology Criteria for Adverse Events 5.0
Late Toxicity [greater than 3 months]
According to the Common Terminology Criteria for Adverse Events 5.0
Patient-reported Quality of Life [1 month, 3 months, and 6 months]
Assessed by EORTC quality of life questionnaires
Local Control [up to 1 year]
Assessed radiographically
Rate of Reirradiation/Salvage Surgery [up to 1 year]
Due to instability or symptomatic progression