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

NCT02145286 | Unknown DMC

• 1 other identifier: 16964
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Bone Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Single Treatment Pain Scores

  Up to 4 weeks following treatment

• Paired Dose Pain Score Comparison

  Up to 4 weeks following treatment

• Post Treatment Measures

  Up to 12 months following treatment

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

Stereotactic Body Radiation Therapy

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

SBRT is a high dose and highly conformal radiation dose treatment with the goal of rapid tumor killing and/or ablation of tumors

Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul W. Read, MD: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul W Read, MD, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 22, 2014
• Study Start: October 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)