Phase 3
Completed N=160
A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms
Source: ClinicalTrials.gov NCT02163226 ↗Enrolled (actual)
160
Serious AEs
18.8%
Results posted
Nov 2021
Primary outcomePrimary: Number of Intent- to- Treat Patients With Pain Response by Treatment — 19; 34; 24; 36 Participants — p=.03
◆ Published Evidence
Highly cited
226citations · ~32 / year
Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy for Pain Relief in Patients With Predominantly Nonspine Bone Metastases: A Randomized Phase 2 Trial.
Summary
The goal of this clinical research study is to learn if 1 large dose of radiation therapy is better at controlling pain from cancer that has spread to the bones than 10 smaller doses of radiation. Researchers also want to learn if 1 large dose of radiation therapy can help decrease the use of drugs to control the pain, and if it can help to control the disease.
Linked Publications
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Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy for Pain Relief in Patients With Predominantly Nonspine Bone Metastases: A Randomized Phase 2 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Intent- to- Treat Patients With Pain Response by Treatment |
19; 34; 24; 36; 17; 31 | .03 sig |
| PRIMARY Number of Evaluable Participants With Pain Response by Treatment |
19; 34; 24; 36; 17; 32 | .01 sig |
| SECONDARY Number of Participants With Toxicity Associated With Treatment |
4; 1; 2; 0; 4; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a pathologic diagnosis of malignancy
- Patients with any radiographic evidence of bone metastases, including plain x-ray, bone scan, computed tomography (CT) scan, magnetic resonance imaging (MRI), or positron emission tomography (PET) scan
- Patients with pain or dysaesthesia
- Patients with a life expectancy of more than 3 months
- Patients able to complete pain assessment and quality of life surveys
- Patients with multiple osseous sites are eligible; however should not treat more than 3 separate radiation treatment fields concurrently.
- Patients with surgery for osseous metastases are allowed.
Exclusion Criteria
- Patients with prior radiation therapy to the treatment site
- Patients with a current, untreated spinal cord compression
- Patients with a radiographic or pathologic fracture to the treatment site
- Patients with painful metastases to hands and feet that need to be radiated on protocol
- Patients previously treated with radioactive isotope (e.g. Sr89) within 30 days of randomization
Data sourced from ClinicalTrials.gov (NCT02163226) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.