Metastases, Palliative Radiotherapy
Conditions
Brief summary
The goal of this clinical trial is to evaluate the feasibility of single-blind randomization between two palliative regimens - standard 24 Gray in 3 fractions vs a high-dose (Hi-D) 27 Gray in 3 fractions with dose escalation within the tumor in participants with bulky metastatic cancer. The main question
Interventions
RADIATIONPalliative Radiotherapy
standard dose RT
Sponsors
British Columbia Cancer Agency
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must meet all the following criteria to be eligible for participation in this study: * Age 18 or older. * Able to provide informed consent * Patient has histologically confirmed solid tumour malignancy * ECOG performance status 0 - 2 * Life Expectancy \> 6 months * 1-5 target lesions larger than 5cm * A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment * Not suitable for or declined curative-intent treatment * Subject has had a CT neck, chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and with 12 weeks of treatment * MRI spine for patients receiving RT to vertebral or paraspinal metastases * Patient is judged able to: * Maintain a stable position during therapy * Tolerate immobilization device(s) that may be required to deliver radiation safely
Exclusion criteria
* \- Hematologic malignancy. * Disease limited to intracranial sites * Serious medical co-morbidities precluding radiotherapy * Bone metastases with no soft tissue component * Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs. * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of accrual | From open to accrual to close to accrual (24 months) | ≥20 participants enrolled within 24 months from first patient accrued |
| Feasibility of blinding | From enrollment to RT completion. | Trial Assignment Questionnaire administered post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare changes in local control | From enrollment to end of study, accessed at 6 weeks, and month 3,12,18,24 | Kaplan-Meier curves; stratified log-rank test |
| Compare changes in OS | From enrollment to end of study at 24 months or death | Time from randomization to death from any cause. Kaplan-Meier; stratified log-rank. |
Countries
Canada
Contacts
Primary ContactSandy Chang
Outcome results
None listed