Recruiting

SBRT

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT04177056

Conditions

Bone Metastases

Prostate Cancer

Breast Cancer

Renal Cell Carcinoma

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SBRT

Study Details

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.

Conditions

Bone Metastases

Prostate Cancer

Breast Cancer

Renal Cell Carcinoma

Melanoma

Study ID

NCT04177056

Start date

Dec 4, 2020

Status verified date

Jul, 2021

Completion date

Jan 1, 2023

Anticipated

Primary completion date

Mar 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stereotactic Body Radiotherapy

High dose SBRT to lesion(s) of interest.

Interventions

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 measure

  • Overall Pain Response [ Time Frame: 3 months after treatment ]

Central Contacts and Locations

Central contacts

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Aug 2, 2021

Last verified

Jul, 2021

Keywords

  • SOLAR-P
  • SBRT
  • Bone metastases
  • stereotactic
  • pain relief
  • quality of life
  • palliation
  • low alpha beta
  • radioresistant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2021-08-02.