Bone MetastasesPhase 3NCT06065449
A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases
A Phase 3 study testing Radiation Therapy in people with Bone Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Radiation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 27 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- The effects of radiation therapy on the developing human fetus are unknown. For this reason and because radiation therapy as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- 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.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 weeks after completion of radiation therapy.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Quynh Nguyen, M D, 713-563-2450, qnnguyen@mdanderson.org
Quynh Nguyen,, M D
About this study
To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.
Read the detailed description
Primary Objectives:
- 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. The 3-month pain response will be used as the primary endpoint in trial design and for powering the test of the study's primary hypothesis of pain response.
Secondary Objectives:
- 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.
- To evaluate narcotics utilization converted to OMED (oral Morphine Equivalent Dose) compared to baseline prior to radiotherapy in both treatment arms.
- To evaluate rate of re-irradiation in both treatment arms.
- To evaluate rate of pathologic fracture in both treatment arms.
- To report overall survival, time from end of radiation treatment to date of death from any cause.
- To report both acute and long-term toxicity associated with radiotherapy in both treatment arms.
- To report of rate of salvage surgery after radiotherapy in both treatment arms.
- To report quality of life outcome measures defined in PROMIS study
- Conditions
- Bone Metastases
- Being tested
- Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion: an average of 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start24 Jan 2024
- Primary completion27 Jun 2027 (estimated)
- Study completion27 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quynh Nguyen, M D, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065449
- Sponsor's protocol ID
- 2022-0776
- Other IDs
- NCI-2023-07923
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases
- ClinicalTrials.gov ID
- NCT06065449
- Acronym / sponsor ID
- 2022-0776
- Conditions
- Bone Metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 27 Jun 2027 (estimated)
- Study completion
- 27 Jun 2027 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.
Detailed description
Primary Objectives:
- 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. The 3-month pain response will be used as the primary endpoint in trial design and for powering the test of the study's primary hypothesis of pain response.
Secondary Objectives:
- 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.
- To evaluate narcotics utilization converted to OMED (oral Morphine Equivalent Dose) compared to baseline prior to radiotherapy in both treatment arms.
- To evaluate rate of re-irradiation in both treatment arms.
- To evaluate rate of pathologic fracture in both treatment arms.
- To report overall survival, time from end of radiation treatment to date of death from any cause.
- To report both acute and long-term toxicity associated with radiotherapy in both treatment arms.
- To report of rate of salvage surgery after radiotherapy in both treatment arms.
- To report quality of life outcome measures defined in PROMIS study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard Dose | Experimental | Drug: Radiation TherapyParticipants 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. |
| Arm 2 - High Dose | Experimental | Drug: Radiation TherapyParticipants will receive either 1 radiation treatment a day for 5 days, or 1 radiation treatment given on 1 day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyArm 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). | Drug | Arm 1 - Standard Dose, Arm 2 - High Dose |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Quynh Nguyen, M D principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation Therapy in people with Bone Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quynh Nguyen, M D ((713) 563-2450, qnnguyen@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.