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

NCT04177056 | Unknown

• 1 other identifier: 7905
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Pain Response

  Assessed using the Brief Pain Inventory

  3 months after treatment

Secondary Outcomes (6)

• Overall Pain Response

  6 months after treatment

• Acute Toxicity

  3 months or less

• Late Toxicity

  greater than 3 months

• Patient-reported Quality of Life

  1 month, 3 months, and 6 months

• Local Control

  up to 1 year

Study Arms (1)

Stereotactic Body Radiotherapy

EXPERIMENTAL

High dose SBRT to lesion(s) of interest.

Radiation: SBRT

Interventions

SBRT RADIATION

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.

Stereotactic Body Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of prostate cancer, renal cell carcinoma, or melanoma
• Radiographic evidence of bone metastases requiring treatment for pain
• Brief Pain Inventory score of ≥ 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Juravinski Cancer Centre Foundation: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 34479581 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms; Carcinoma, Renal Cell; Melanoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Officials

• Anand Swaminath, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Tran, MD

CONTACT

905-387-9711; transt@hhsc.ca

Eric K Nguyen, MD

CONTACT

905-387-9711; eric.nguyen@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 26, 2019
• Study Start: December 4, 2020
• Primary Completion: March 1, 2022
• Study Completion: January 1, 2023
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

CA (1)