Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Bone Metastases

Cancer Metastatic Clinical Trial

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 Bone Metastases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06391242
• Other study ID #: SC29
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 1, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: April 2024
• Source: Canadian Cancer Trials Group
• Contact: Wendy Parulekar
• Phone: 613-533-6430
• Email: wparulekar[@]ctg.queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: January 1, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Metastatic
• Neoplasm Metastasis

Intervention

Radiation:
• Standard Conventional Radiotherapy
20Gy in 5 fractions
• Stereotactic Body Radiotherapy
30 or 35Gy in 5 fractions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group

Outcome

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