Palliative radiation therapy for metastatic bone disease

1-2 PUNCH: Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

This study tests whether a new way of giving radiation therapy in higher doses over two sessions can help people with metastatic bone disease feel less pain and improve their quality of life compared to the usual single dose treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Cincinnati (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT05115331 on ClinicalTrials.gov

What this trial studies

This Phase III study evaluates the effectiveness of hypofractionated and dose-escalated radiation therapy for patients with metastatic bone disease. Participants will be randomly assigned to receive either a conventional single fraction of radiation or an experimental regimen with a higher dose spread over two fractions. The study aims to assess pain relief and quality of life improvements through baseline and follow-up evaluations. The hypothesis is that the experimental treatment will yield better pain control and longer-lasting responses compared to standard care.

Who should consider this trial

Good fit: Ideal candidates include adults with confirmed solid cancer malignancies and 1-3 new painful metastatic bone lesions.

Not a fit: Patients with no new painful metastatic lesions or those with a performance status that exceeds the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide more effective pain relief and improved quality of life for patients suffering from metastatic bone disease.

How similar studies have performed: Previous studies have shown that radiation therapy is effective for palliative care in metastatic bone disease, but this specific hypofractionated approach is being tested for the first time.

Eligibility criteria

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed history of solid cancer malignancy (including small cell lung cancer).
2. Patients must have 1-3 new or newly painful metastatic lesions to bone as defined by CT scan, MRI, or PET scan. Lesions must be located in a long bone, pelvis/hip, spine, sacrum, or ribs. A lesion is "new" if it has occurred since any previous imaging, or if new cancer diagnosis, or new at presentation. A newly painful lesion is one that had been visible on previous imaging, but was either asymptomatic or minimally painful so that no treatment was pursued.
3. There must be clearly attributable pain associated with the 1-3 new metastatic bone lesion(s) as documented on the Brief Pain Inventory and per investigator's determination that these imaging findings are consistent with the patient's described BPI pain from metastatic lesion(s).
4. Age ≥18 years.
5. ECOG performance status ≤3 or (Karnofsky ≥40%, see Appendix A).
6. 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 in the opinion of the investigator.
7. Ability to understand and the willingness to sign written informed consent.

Exclusion Criteria:

1. Patients who have had or will have chemotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to commencing study RT. Patients undergoing treatment with hormonal or endocrine therapies will be eligible for this trial and may continue these through study radiotherapy.
2. Patients with widespread metastatic disease, such that in the opinion of the PI would preclude an investigator from determining the origin of bone disease-related pain and/or response to palliative treatment.
3. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
4. Patients with complicated bone metastases, defined as having at least one or more of the following criteria:

   1. Nerve root compression
   2. Prior radiation to the spinal cord at that bone level
   3. Impending (score of 9 or more on Mirel's Criteria) or existing pathologic fracture
   4. Spinal cord compression
   5. cauda equina syndrome
5. Patients who have been previously radiated to the primary anatomic site for which they are being considered for this trial, or have had surgical fixation of the site. However, patients may have undergone previous courses of radiotherapy to a primary site or separate site of metastatic disease if in the opinion of the investigator the patient will be able to tolerate palliative RT.
6. Patients with uncontrolled intercurrent illness.
7. Pregnant women are excluded from this study.
8. Life expectancy of under 3 months in the opinion of the treating investigator.
9. Liquid malignancies, including myeloma, lymphoma.
10. Judgment by the investigator that the patient is unsuitable to participate in the study or the patient is unlikely to comply with study procedures, restrictions and requirements.

Where this trial is running

Cincinnati, Ohio

• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Timothy Struve, MD — University of Cincinnati
• Study coordinator: UCCC Clinical Trials Office

Conditions Metastatic Bone Tumor; Metastatic Bone Disease