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

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.

Study Overview

• Status: Unknown
• Conditions: Metastatic Bone Lesion
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient has 1-3 major painful osseous metastases (target lesions)
• Radiographic evidence (CT, MR, or PET CT) consistent with osseous metastatic disease on CT, MR, or PET CT obtained within 4 weeks of treatment will be used for pre-study treatment delivery. The GTV of the target lesions will be determined from this radiographic study and must be ≤ 250 cubic centimeters.

NOTE: Patient is still eligible if a diagnostic image set is not available within 4 weeks of treatment if the patient will undergo a kVCT simulation in the Department of Radiation Oncology with contouring directly onto this image set.

• Patient is medically able to undergo palliative radiation therapy
• Patient has pain that is persistent and distinguishably associated with the target sites to be treated
• Planning Target Volume 1 (PTV1) must be > 5mm from the spinal cord or brain
• Women of Childbearing age and men must consent to use adequate contraception for six months following study entry

Exclusion Criteria:

• Inability to lie on the treatment table for 1 hour
• Systemic therapeutic radionuclide delivery within 30 days prior to treatment
• Target lesions have been previously treated with external beam radiation
• Long bone target lesions with a Mirels fracture score >7
• Unstable bone in the target lesion requiring surgical stabilization
• PTV1 is located within 5mm of spinal cord or brain
• A serious, uncontrolled medical disorder
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation Therapy; Stereotactic Body Radiation Therapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dose	Determine the optimal dose range for treatment of osseous bone metastases with single SBRT (Stereotactic Body Radiation Therapy) treatment using the STAT RAD (right away/radiation) workflow	Up to 12 months following treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single Treatment Pain Scores	Patients will complete questionnaires to determine whether the treatment of osseous bone metastases with single treatment using the STAT RAD workflow results in a significant change in pain scores at 4 weeks following treatment of patients with good prognosis, compared to baseline scores	Up to 4 weeks following treatment
Paired Dose Pain Score Comparison	Patient questionnaires will be used to estimate the difference in the mean change in pain score from baseline to 4 weeks following treatment of patients with good prognosis between pairs of dose levels among those in the range of optimal doses	Up to 4 weeks following treatment
Post Treatment Measures	Patients will complete questionnaires to capture pain scores of the treated lesion(s), analgesic use, patient functional status, patient quality of life, and patient satisfaction at 1,4,8, and 12 weeks and at 6 and 12 months following treatment. Rates of radiation-retreatment within one year will also be captured for the treated target lesion(s).	Up to 12 months following treatment

Collaborators and Investigators

• Sponsor: Paul W. Read, MD
• Investigators: Principal Investigator: Paul W Read, MD, PhD, University of Virginia

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO