Rapid Radiation Therapy for Painful Osseous Metastatic Disease

NCT01391234 | Completed Results DMC

• 1 other identifier: 15625
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Bone Metastases

Keywords

Metastatic bone disease; Bone metastases; Radiation therapy; TomoTherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Complete Response, Partial Response, or Stable Pain After Receiving Treatment Via the STAT RT Workflow at 12-months

  The Brief Pain Inventory (BPI) and Oral Morphine Equivalent Doses (OMED) were used to categorize the number of participants who had a Complete Response (no pain), Partial Response (pain reduction), Stable Pain (no change in pain), and Pain Progression at 12 months after receiving treatment via the STAT RT workflow.

  12 months after treatment

Secondary Outcomes (25)

• Number of Participants With Treatment Toxicity

  12 months after treatment

• Number of Participants With an Improved Quality of Life Function Score at 1 Week Post Treatment

  1 Week Post Treatment

• Number of Participants With an Improved Quality of Life Function Score at 4 Weeks After Initial Treatment

  4 weeks post treatment

• Number of Participants With an Improved Quality of Life Function Score at 8 Weeks After Initial Treatment

  8 weeks post initial treatment

• Number of Participants With an Improved Quality of Life Function Score at 12 Weeks Post Initial Treatment

  12 weeks post treatment.

Study Arms (1)

STAT RT planning and delivery workflow

EXPERIMENTAL

single arm

Radiation: STAT RT planning and delivery workflow

Interventions

STAT RT planning and delivery workflow RADIATION

* 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.

Also known as: TomoTherapy-based Radiation Therapy

STAT RT planning and delivery workflow

Eligibility Criteria

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

You may qualify if:

• Patient has a biopsy proven diagnosis of cancer. The osseous metastatic lesions do not need to be biopsied.
• Patients with multiple myeloma are eligible for the study.
• Patient has 1-3 major painful osseous metastases (target lesions) from any primary cancer or unknown primary cancer.
• Long bone target lesions must have a Mirels fracture score of ≤ 7.
• Patients with spinal cord compression from vertebral body metastases are not eligible.
• Target lesions have not previously been treated with radiation.
• Radiation oncologist determines that the patient is medically able to undergo palliative radiation therapy.
• Patient has target lesions that are radiographically consistent with metastatic disease on CT, MR, or PET CT obtained within 8 weeks of treatment.
• Persistent distinguishable pain associated with target sites to be treated.
• Patient average BPI pain score for last 72 hours at specified location is \> 3 (0-10 scale)
• Patients may have additional non-painful or minimally painful osseous metastases (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the BPI compared to the site(s) treated)
• The patient may have previously been treated with radiation therapy to other body sites, but not to the target lesions.
• The patient may have previously or currently be undergoing chemotherapy or bisphosphonate therapy.
• The patient will be able understand English (or a medical interpreter for their native language must be available for all study visits).
• years of age or older.

You may not qualify if:

• Inability to lie flat on table for treatment
• Patient with \< 12 weeks life expectancy
• Systemic radionuclide delivery within 30 days prior to treatment
• Epidural compression of spinal cord or cauda equine
• Spinal canal compromise \> 25%
• Unstable spine requiring surgical stabilization
• Target lesions have previously been treated with radiation.
• Tumor located within 5mm of spinal cord or cauda equina.
• A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the patient to receive protocol therapy.
• Pregnant and breastfeeding women are excluded from this study.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Paul Read
• Organization: University of Virginia Department of Radiation Oncology

PWR3U@hscmail.mcc.virginia.edu

(434) 924-5191

Study Officials

• Paul W Read, MD

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: July 11, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: May 1, 2015
• Last Updated: December 1, 2022
• Results First Posted: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)