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Stereotactic Body Radiotherapy for Radioresistant Bone Metastases (SOLAR-P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04177056
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
Juravinski Cancer Centre Foundation
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 4, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : January 1, 2023


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.




Primary Outcome Measures :
  1. Overall Pain Response [ Time Frame: 3 months after treatment ]
    Assessed using the Brief Pain Inventory


Secondary Outcome Measures :
  1. Overall Pain Response [ Time Frame: 6 months after treatment ]
    Assessed using the Brief Pain Inventory

  2. Acute Toxicity [ Time Frame: 3 months or less ]
    According to the Common Terminology Criteria for Adverse Events 5.0

  3. Late Toxicity [ Time Frame: greater than 3 months ]
    According to the Common Terminology Criteria for Adverse Events 5.0

  4. Patient-reported Quality of Life [ Time Frame: 1 month, 3 months, and 6 months ]
    Assessed by EORTC quality of life questionnaires

  5. Local Control [ Time Frame: up to 1 year ]
    Assessed radiographically

  6. Rate of Reirradiation/Salvage Surgery [ Time Frame: up to 1 year ]
    Due to instability or symptomatic progression



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Eric K Nguyen, MD 905-387-9711 nguyener@hhsc.ca

Locations
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Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Anand Swaminath, MD    905-387-9711    swaminath@hhsc.ca   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Juravinski Cancer Centre Foundation
Investigators
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Principal Investigator: Anand Swaminath, MD Hamilton Health Sciences Corporation
  Study Documents (Full-Text)

Documents provided by Hamilton Health Sciences Corporation:
Study Protocol  [PDF] November 24, 2020

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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT04177056    
Other Study ID Numbers: 7905
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamilton Health Sciences Corporation:
stereotactic
SBRT
Bone mets
palliation
pain relief
quality of life
Additional relevant MeSH terms:
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Neoplasm Metastasis
Carcinoma, Renal Cell
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases