Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Bone Metastases

A Randomized Phase III Trial Comparing Stereotactic Body Radiotherapy to Conventional Palliative Radiotherapy (SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Participants With Painful Bone Metastases

This study is being done to answer the following question: Is Stereotactic Body Radiation Therapy or SBRT (a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer, while keeping the radiation beams away from the healthy parts of the body that surround the cancer) better for pain relief than the standard treatment of conventional radiation therapy or CRT (a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area)

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Metastatic
• Intervention / Treatment: Radiation: Standard Conventional Radiotherapy; Radiation: Stereotactic Body Radiotherapy

Detailed Description

This is a multi-centre, phase III randomized controlled trial comparing SBRT to conventional palliative EBRT in patients with solid tumours and a dominant painful non-spine bone metastasis as defined by a worst pain score of 2 or greater. 230 participants will be enrolled to the study. Participants will have radiation for 5 treatments (conventional palliative EBRT 20Gy/5; SBRT 30Gy/5 or 35Gy/5) and then will be followed for pain response and radiological progression at 3 and 6 months post treatment.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wendy Parulekar; Phone Number: 613-533-6430; Email: wparulekar@ctg.queensu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologic confirmation of solid tumour.
• Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the BPI attributed to that dominant site
• Expected overall survival of greater than 6 months as determined by the treating physician
• Suitable for protocol defined SBRT and CRT.
• Stable pain with no immediate plan to alter analgesic regimen.
• ECOG performance status of 0-2.
• Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate

Exclusion Criteria:

• Metastases of the hands, feet, cranium and spine (including sacrum).
• Bone metastasis arising from a small cell or germ cell.
• Radionuclide therapy within 30 days of randomization.
• Patient treated with prior palliative RT to the dominant painful bone metastasis site (prior radiation exposure is permitted if prior to development of the dominant metastasis and would not influence the applicability of either treatment arm of the current study).
• Received systemic chemotherapy within 1 week of the protocol RT, or who are expected/planned to receive chemotherapy within one week of completing protocol RT.
• Participants with an unstable pathologic fracture at the dominant painful bone metastasis, or for whom surgical fixation would be the preferred intervention if possible.
• Pregnant or lactating individuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Conventional Radiotherapy	Radiation: Standard Conventional Radiotherapy; 20Gy in 5 fractions
Experimental: Stereotactic Body Radiotherapy	Radiation: Stereotactic Body Radiotherapy; 30 or 35Gy in 5 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete pain response utilizing the Cochran-Mantel-Hanzeal test	27 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain response pattern at 3 months: partial, stable or progressive pain	27 months
Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain);	27 months
Re-irradiation rate within the 6-month follow-up period	27 months
Incidence of fracture at the radiation target site	27 months
Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5	27 months
Imaging-based local control rates at 3 and 6 months post-treatment	27 months
Patient reported outcomes utilizing EORTC QLQ-C30	27 months
Patient reported outcomes utilizing EORTC QLQ-BM22	27 months
Cost effectiveness utilizing EQ-5D-5L	27 months

Collaborators and Investigators

• Sponsor: Canadian Cancer Trials Group
• Investigators: Study Chair: Arjun Sahgal, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Study Chair: Tim Nguyen, London Regional Cancer Program, London, ON, Canada

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: SC29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As per CCTG policies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No