NCT05115331

Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized Phase III study evaluating the efficacy of hypofractionated and dose-escalated palliative radiation therapy in metastatic bone disease (MBD). Patients will be randomized 1:1 to the conventional (8 Gy in a single fraction) and experimental (16 Gy in 2 fractions) groups with baseline and subsequent assessment of both pain and quality of life metrics.

Detailed description

Metastatic Bone Disease (MBD) has been demonstrated to be a common clinical problem, and often presents with severe, if not debilitating pain. This often proceeds to affect a patient's emotional and even global functioning. Radiation therapy is an effective treatment commonly used in the palliation of these metastatic lesions, and improvements in QOL scores are associated with response to radiotherapy treatment. Although both 30 Gy/10 fractions and 8 Gy in a single fraction are considered standard of care in the palliative setting, single fraction treatment is associated with increased rates of local failure and retreatment. Considering that patients with MBD often have life-limiting disease, and frequently have great difficulty with undergoing extended radiotherapy treatments, there is a significant unmet need for palliative treatments that are effective, safe, timely, and provide a durable local tumor and pain control. The investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose will result in a higher proportion of patients responding to treatment, and will also lead to more durable responses.

Conditions

• Metastatic Bone Tumor

Interventions

Type	Name	Description
RADIATION	Experimental Radiation Dose	16 Gy in 2 fractions
RADIATION	Conventional Radiation Dose	8 Gy in a single fraction

Timeline

• Start date: 2021-11-24
• Primary completion: 2023-07-13
• Completion: 2025-11-24
• First posted: 2021-11-10
• Last updated: 2025-05-31

Locations

1 site across 1 country: United States