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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Renal Cell Carcinoma; Breast Cancer; Prostate Cancer; Bone Metastases
• Intervention / Treatment: Radiation: SBRT

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan Tran, MD; Phone Number: 63123 905-387-9711; Email: transt@hhsc.ca
• Study Contact Backup: Name: Eric K Nguyen, MD; Phone Number: 63123 905-387-9711; Email: eric.nguyen@medportal.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Juravinski Cancer Centre
      • Contact: Anand Swaminath, MD; Phone Number: 905-387-9711; Email: swaminath@hhsc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Pain Response	Assessed using the Brief Pain Inventory	3 months after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Juravinski Cancer Centre Foundation
• Investigators: Principal Investigator: Anand Swaminath, MD, Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2020
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (ACTUAL): November 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; pain relief; SBRT; Bone metastases; palliation; stereotactic; SOLAR-P; low alpha beta; radioresistant
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Neoplastic Processes; Carcinoma, Renal Cell; Neoplasm Metastasis
• Other Study ID Numbers: 7905 (OTHER: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No