Radiation Therapy for Cancer with Bone Metastasis

(PREEMPT Trial)

Recruiting at 516 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 trial explores whether adding radiation therapy to usual care can better prevent bone-related problems in cancer patients with high-risk bone metastases that aren't yet causing symptoms. Radiation therapy uses high-energy x-rays to target and kill cancer cells. The trial compares usual care alone with usual care plus radiation therapy to determine which is more effective in reducing complications like fractures or severe pain. Suitable participants have cancer with more than five areas of spread, including specific high-risk bone metastases, and are not currently experiencing significant pain. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that radiation therapy is likely to be safe for humans?

Research has shown that patients with cancer that has spread to the bones usually tolerate radiation therapy well. In one study of 548 cases, only about 3.2% of patients experienced severe side effects, indicating that most did not encounter major issues. Another study found that using radiation on spinal cancer not only reduced pain but was also generally safe for patients. Overall, while radiation therapy can have side effects, serious problems appear to be rare according to these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about this radiation therapy approach for cancer with bone metastasis because it combines conventional radiation therapy (RT) or stereotactic body radiation therapy (SBRT) with the standard of care (SOC), potentially enhancing treatment effectiveness. Unlike standard treatments that mainly rely on systemic anti-cancer drugs and bone-modifying agents, this method uses targeted radiation to directly address bone metastases. This targeted approach aims to reduce pain and improve quality of life more efficiently. Additionally, the therapy's short treatment duration—up to just five days—could offer faster relief compared to some longer-term treatment options.

What evidence suggests that radiation therapy might be an effective treatment for preventing bone-related complications in cancer patients with high-risk bone metastases?

Research has shown that radiation therapy can reduce bone problems in patients with high-risk bone cancer spread. In this trial, participants in Arm II will receive radiation therapy alongside standard care. Studies have found that stereotactic body radiation therapy (SBRT) offers better long-term pain relief than traditional radiation. In some cases, SBRT also prevents further cancer spread. While these studies primarily focused on painful bone cancer spread, similar benefits might exist for those without symptoms but at high risk. Adding radiation therapy to regular treatment may more effectively prevent issues like fractures or spinal cord compression than regular treatment alone. ^{1 2 4 5 6}

Who Is on the Research Team?

Erin F Gillespie

Principal Investigator

NRG Oncology

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 9 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 for RT planning 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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9627033/

Efficacy and safety of stereotactic body radiotherapy for painful ... This study shows that for painful bone metastases, patients with SBRT experienced better pain relief 3 months after radiation than patients with cRT.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814927

Stereotactic Body and Conventional Radiotherapy for ... In this systematic review and meta-analysis, patients with painful bone metastases experienced similar overall pain response after SBRT compared with cEBRT.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624000245

Clinical Outcomes After Stereotactic Body Radiation ... There are limited data available on clinical outcomes after stereotactic body radiation therapy (SBRT) for nonspinal bone metastases.

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89863-2/fulltext

Efficacy and safety of SBRT for spine metastases Globally, despite the heterogeneity of the data derived from these randomized studies, SBRT resulted in improved long-term pain control and it ...

5. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00002-2/fulltext

Clinical Outcomes Among Patients Treated With ... With median follow-up 19.4 months, 1- and 2-year rates of local control were 94% and 89%, locoregional control was 83% and 67%, progression-free ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S240563082300112X

Efficacy and safety analysis in metastatic cancer patients ... Response to radiotherapy was observed in 548 (83.0 %) cases and CTCAE toxicity grade > 3 was observed in 21 (3.2 %) cases. •. An increasing number of RT courses ...