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Rapid Radiation Therapy for Painful Osseous Metastatic Disease

NCT01391234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-12-01

Study results available
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Summary

The purpose of this research study is to evaluate the safety and effectiveness of an experimental workflow that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (tumors that originally came from another organ and have spread to bones causing pain) or multiple myeloma (a type of cancer that begins in white blood cells that produce antibodies).

The current standard of care radiation treatment planning and delivery takes 2 to 3 weeks from start to finish. The investigators have developed an experimental workflow: a radiation treatment planning and delivery workflow called "STAT RT" (STAT means "right away", and RT means radiation therapy). This experimental workflow may shorten the time it takes to plan and treat painful bone metastases to 1 week or less. All steps in this process will be performed within the current standard of care but in a shorter time frame to allow treatment to start sooner.

The investigators will evaluate effectiveness by requesting patients to complete pain and quality of life questionnaires before and after treatment. The investigators will also be collecting additional information from their treatments that will help us make future workflows even more efficient.

Conditions

Interventions

RADIATION

STAT RT planning and delivery workflow

* Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Paul W Read, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-07-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01391234 on ClinicalTrials.gov