This phase III trial compares stereotactic body radiation therapy (SBRT) to conventional palliative radiation therapy for pain management of cancer that has spread from where it first started (primary site) to the bones (bone metastases). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Conventional radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Palliative radiation therapy is radiation therapy intended to treat symptoms (such as pain) instead of the disease itself. Increasing doses and different treatment schedules of SBRT against conventional radiation dosing and treatment scheduling may better manage painful bone metastases.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06065449.
Locations matching your search criteria
United States
Texas
Conroe
MD Anderson in The WoodlandsStatus: Active
Contact: Quynh-Nhu Nguyen
Phone: 713-563-2450
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Quynh-Nhu Nguyen
Phone: 713-563-2300
MD Anderson West HoustonStatus: Active
Contact: Quynh-Nhu Nguyen
Phone: 713-563-2450
League City
MD Anderson League CityStatus: Active
Contact: Quynh-Nhu Nguyen
Phone: 713-563-2450
Sugar Land
MD Anderson in Sugar LandStatus: Active
Contact: Quynh-Nhu Nguyen
Phone: 713-563-2450
PRIMARY OBJECTIVE:
I. Pain response will be assessed at 2 weeks, 1 month, 3 months and then every 3 months post-treatment and will be determined based on International Pain Consensus Criteria between the two treatment arms.
SECONDARY OBJECTIVES:
I. The local failure rate will be determined by radiographic response after radiation therapy. If the radiographic reports are indeterminate, the local failure rate will be based on second consecutive radiographic report showing local progression.
II. To evaluate narcotics utilization converted to OMED (oral morphine equivalent dose) compared to baseline prior to radiotherapy in both treatment arms.
III. To evaluate rate of re-irradiation in both treatment arms.
IV. To evaluate rate of pathologic fracture in both treatment arms.
V. To report overall survival, time from end of radiation treatment to date of death from any cause.
VI. To report both acute and long-term toxicity associated with radiotherapy in both treatment arms.
VII. To report of rate of salvage surgery after radiotherapy in both treatment arms.
VIII. To report quality of life outcome measures defined in Patient-Reported Outcomes Measurement Information System (PROMIS) study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo conventional palliative radiation therapy for 1 or 5 fractions over 5-10 minutes each. Patients also undergo magnetic resonance imaging (MRI), positron emission tomography (PET)/computed tomography (CT), PET, CT, prostate specific membrane antigen (PSMA) scan, bone scan, x-ray imaging, or other standard imaging scans throughout the trial.
ARM II: Patients undergo SBRT for 2 or 3 fractions over 5-10 minutes each. Patients also undergo MRI, PET/CT, PET, CT, PSMA scan, bone scan, x-ray imaging, or other standard imaging scans throughout the trial.
After completion of study treatment, patients are followed up at 1 month, then every 3 months for the first year, followed by every 3-6 months after that for up to 3 years total.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorQuynh-Nhu Nguyen
