Cancer Metastatic
Conditions
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.
Interventions
RADIATIONStandard Conventional Radiotherapy
20Gy in 5 fractions
RADIATIONStereotactic Body Radiotherapy
30 or 35Gy in 5 fractions
Sponsors
Canadian Cancer Trials Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 or spine (including sacrum) as the dominant/index pain site. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pain response utilizing the Cochran-Mantel-Hanzeal test | 27 months |
Secondary
| 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 |
Countries
Canada
Contacts
CONTACTWendy Parulekar
STUDY_CHAIRArjun Sahgal
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
STUDY_CHAIRTim Nguyen
London Regional Cancer Program, London, ON, Canada
Outcome results
None listed