Phase 3 N=160 Randomized Treatment

A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms

Bone Metastases

Bottom Line

View on ClinicalTrials.gov: NCT02163226 ↗

Enrolled (actual)

160

Serious AEs

18.8%

Results posted

Nov 2021

Primary outcome: Primary: Number of Intent- to- Treat Patients With Pain Response by Treatment — 19; 34; 24; 36 Participants — p=.03

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Hypofractionated Radiation Treatment (Radiation); One Radiation Treatment (Radiation); Questionnaire (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Sep 2020

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02163226). 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.