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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose RT | Experimental | 27Gy in 3 fractions with boost |
|
| Standard Dose Palliative RT | Active Comparator | 24Gy in 3 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Radiotherapy | Radiation | standard dose RT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of accrual | ≥20 participants enrolled within 24 months from first patient accrued | From open to accrual to close to accrual (24 months) |
| Feasibility of blinding | Trial Assignment Questionnaire administered post-treatment. | From enrollment to RT completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare changes in local control | Kaplan-Meier curves; stratified log-rank test | From enrollment to end of study, accessed at 6 weeks, and month 3,12,18,24 |
| Compare changes in OS | Time from randomization to death from any cause. Kaplan-Meier; stratified log-rank. |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandy Chang | Contact | 6048776000 | sandy.chang@bccancer.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Wei Liu, MD, FRCPC | BC Cancer - Vancouver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer - Vancouver | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Palliative Radiotherapy |
| Radiation |
high-dose RT |
|
| From enrollment to end of study at 24 months or death |