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

July 26, 2021 updated by: Hamilton Health Sciences Corporation
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

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stephan Tran, MD
  • Phone Number: 63123 905-387-9711
  • Email: transt@hhsc.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 months after treatment
Assessed using the Brief Pain Inventory
3 months after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Juravinski Cancer Centre Foundation

Investigators

  • Principal Investigator: Anand Swaminath, MD, Hamilton Health Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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