Clinical trial NCT06391242: Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
Official title: A Randomized Phase III Trial Comparing Stereotactic Body Radiotherapy to Conventional Palliative Radiotherapy (SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Participants With Painful Non-Spine Bone Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cancer Metastatic
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
First posted: 2024-04-30
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete pain response utilizing the Cochran-Mantel-Hanzeal test
timeFrame: 27 months
Secondary outcomes:
measure: Pain response pattern at 3 months: partial, stable or progressive pain
timeFrame: 27 months
measure: Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain);
timeFrame: 27 months
measure: Re-irradiation rate within the 6-month follow-up period
timeFrame: 27 months
measure: Incidence of fracture at the radiation target site
timeFrame: 27 months
measure: Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5
timeFrame: 27 months
measure: Imaging-based local control rates at 3 and 6 months post-treatment
timeFrame: 27 months
measure: Patient reported outcomes utilizing EORTC QLQ-C30
timeFrame: 27 months
measure: Patient reported outcomes utilizing EORTC QLQ-BM22
timeFrame: 27 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Quebec City
country: Canada
facility: Hotel-Dieu de Quebec
state: Quebec
Study officials:
affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
name: Arjun Sahgal
role: STUDY_CHAIR
affiliation: London Regional Cancer Program, London, ON, Canada
name: Tim Nguyen
role: STUDY_CHAIR
References: