NCT02145286

Phase 1/2 Study to Determine Optimal Dose for Treating Bone Metastases Using Novel STAT-RT Workflow

A Phase I/II Single Arm Prospective Single Fraction Real-time Stereotactic Body Radiation Therapy Dose Escalation Trial of Rapid Helical TomoTherapy-based Radiation Therapy for Patients With Painful Osseous Metastatic Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Paul W. Read, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate the safety and effectiveness of an experimental procedure called Focused Radiation that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous tumors that originally came from another organ and have spread to bones). In this trial a single fraction of radiation will be given from 8-15 Gray.

Detailed description

The purpose of this research study is to evaluate the safety and effectiveness of an experimental procedure called Focused Radiation that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous tumors that originally came from another organ and have spread to bones). Focused radiation (the radiation is focused on the tumor in the bone with reduced radiation dose to the normal tissues) is used as standard of care treatment for patients with painful metastatic tumors in their spines with just one treatment. In this study, the focused radiation will be used to treat tumors in other bones as well. The current standard of care radiation treatment planning and delivery can take 2 to 3 weeks from start to finish depending on how many treatments are given although the standard of care is to treat patients with 1-10 treatments. The University of Virginia has developed an experimental workflow/process: a radiation treatment planning and delivery workflow called "STAT RAD" (STAT means "right away", and RAD means radiation). This experimental workflow will shorten the time it takes to plan and treat painful bone metastases to 1-2 hours. When only one treatment is given the standard radiation dose is 8 Gray. This has resulted in radiation retreatment rates to the treated bone of 20% in prior studies for persistent or recurrent bone pain. In this study patients will be treated with higher doses of targeted radiation to determine if higher doses, which have been reported to be safely delivered for bone metastases in the spine with very low re-treatment rates, can be safely delivered to non-spine bone metastases. After the treatment, patients will be followed for pain relief in the treated bone, need for pain medication, quality of life, toxicity, and the need to retreat the bone metastasis for persistent or recurrent pain.

Conditions

• Metastatic Bone Lesion

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy	SBRT is a high dose and highly conformal radiation dose treatment with the goal of rapid tumor killing and/or ablation of tumors

Timeline

• Start date: 2013-10-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2014-05-22
• Last updated: 2018-06-12

Locations

1 site across 1 country: United States