A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with pathologic diagnosis of solid primary malignancy with any radiographic report of bone metastases including but not limited to plain x-ray, bone scan, CT scan, MRI, PET/CT scan, PSMA scan, PET fluciclovine scan. The exception is patients diagnosed with multiple myeloma are eligible.

Patients with any pain or discomfort at proposed treatment site.

Patients with life expectancy of 3 months or greater.

Patients able to complete pain assessment and quality of life surveys.

Disqualifiers

Patients with prior radiation therapy to the proposed treatment site.

Patient with current, un-treated cord compression at treatment site.

Patients with a radiographic or pathologic fracture at the proposed treatment site that is not mechanically stable. If this is stabilized mechanically or seen by orthopedic surgery, this site is eligible for enrollment and treated on protocol

Patients with metastases to hand and feet.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiation Therapy

    Drug

    Arm 1: standard 8 Gy delivered in a single fraction or 20 Gy delivered in 5 fractions Arm 2: 16 Gy delivered in a single fraction or 27 Gy delivered in 3 fractions prescribed to planning target volume (PTV).

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Arm 1 - Standard DoseExperimental treatment 1 intervention
Group B: Arm 2 - High DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
through study completion: an average of 1year

Secondary outcomes

Other outcomes

Sponsors and contacts

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