Radiation Therapy for Cancer with Bone Metastasis

(PREEMPT Trial)

Recruiting at 272 trial locations

Overseen By Erin Gillespie

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NRG Oncology

Must be taking: Bone loss prevention

Disqualifiers: Multiple myeloma, Intracranial disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 1 week

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.

Are You a Good Fit for This Trial?

This trial is for cancer patients with more than five metastatic sites, bulky bone disease (≥2 cm), or specific high-risk locations in the bones. It's open to adults over 18 with a performance status indicating they can care for themselves and are up and about more than half of waking hours. Patients with treated brain metastases without leptomeningeal disease may also join.

Inclusion Criteria

I have had a CT or PET scan to check my cancer's spread.

My cancer has spread to more than 5 areas of my body, not including my brain.

I have a large tumor in my bone (2 cm or larger).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiation therapy or continue standard of care for up to 5 days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy

Trial Overview The study compares adding radiation therapy to usual care versus usual care alone for asymptomatic high-risk bone metastases. Radiation aims to prevent complications like fractures or pain needing surgery, delivered in one day or across five days.

How Is the Trial Designed?

Group I: Arm II (RT, SOC) Experimental Treatment 5 Interventions

Patients continue SOC as in Arm I. Patients also undergo conventional RT or SBRT QD for up to 5 days (5 fractions) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and optional blood sample collection on study.

Group II: Arm I (standard of care) Active Control 5 Interventions

Patients continue to receive SOC systemic anti-cancer therapy or observation and bone modifying agents as determined by the treating physician. Additionally, patients optional blood sample collection on study.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+