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

NCT06065449 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2022-0776NCI-2023-07923
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Metastases

Outcome Measures

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

  through study completion: an average of 1year

Study Arms (2)

Arm 1 - Standard Dose

EXPERIMENTAL

Participants will receive either 1 radiation treatment a day for 3 days in a row (not counting weekends or holidays), or Participants will receive 1 radiation treatment given on 1 day.

Drug: Radiation Therapy

Arm 2 - High Dose

EXPERIMENTAL

Participants will receive either 1 radiation treatment a day for 5 days, or 1 radiation treatment given on 1 day.

Drug: Radiation Therapy

Interventions

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).

Arm 1 - Standard Dose; Arm 2 - High Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with multiple osseous sites are eligible; however, should not treat more than three separate isocenters concurrently. Additional isocenters can be treated sequentially.
• Patients with prior surgery for osseous metastases are eligible.
• Patients age 18 years or older. Pediatric patients are usually enrolled on pediatric protocols. There are no adverse data available for patients \< 18 years of age treated with SBRT, therefore children are excluded from this study.
• Patients may receive systemic therapy including chemotherapy, targeted therapy, immunotherapy, or other systemic agents up to and during radiation at treating physician's discretion per standard of care.
• Patients must have adequate organ and marrow function as defined below:
• platelets ≥ 40,000/mcL
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Postmenopausal (no menses in greater than or equal to 12 consecutive months)
• History of hysterectomy or bilateral salpingo-oophorectomy.
• Ovarian Failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
• History of bilateral tubal ligation or another surgical sterilization procedure.

You may not qualify if:

• 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.
• Patients with previously treated with radioactive isotope (e.g. Sr 89) within 30 days of randomization. This can have concomitant effects with radiation therapy.
• Patients with spinal metastases along cervical, thoracic, or lumbar spine are not eligible. However, if the primary site invades the paraspinal or spine region, these are eligible.
• Pregnant patients are not eligible.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Quynh Nguyen, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quynh Nguyen, M D

CONTACT

(713) 563-2450; qnnguyen@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 4, 2023
• Study Start: January 24, 2024
• Primary Completion (Estimated): June 27, 2027
• Study Completion (Estimated): June 27, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)