Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases

Trial Title: Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases

NCT ID: NCT06391242

Condition: Cancer Metastatic

Conditions: Official terms:
Neoplasm Metastasis

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Standard Conventional Radiotherapy
Description: 20Gy in 5 fractions
Arm group label: Standard Conventional Radiotherapy

Intervention type: Radiation
Intervention name: Stereotactic Body Radiotherapy
Description: 30 or 35Gy in 5 fractions
Arm group label: Stereotactic Body Radiotherapy

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 30, 2024

Completion date: January 1, 2028

Lead sponsor:
Agency: Canadian Cancer Trials Group
Agency class: Other

Source: Canadian Cancer Trials Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06391242