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Phase II Pilot Single Arm Prospective Clinical Trial of Rapid Institution of Helical TomoTherapy-based Radiation Therapy for Patients With Painful Osseous Metastatic Disease

Phase 2
18 Years
Open (Enrolling)
Bone Metastases

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Trial Information

Phase II Pilot Single Arm Prospective Clinical Trial of Rapid Institution of Helical TomoTherapy-based Radiation Therapy for Patients With Painful Osseous Metastatic Disease

Background: Osseous metastatic disease causes significant pain, decreased functioning, and
decreased quality of life. Progressive bone destruction can lead to pathologic fractures or
spinal cord compression leading to orthopedic surgery, paralysis, and/or patients becoming
bedridden. Opioids can alleviate pain but have neurologic and gastrointestinal side effects
that further decrease quality of life. Radiation therapy can effectively reduce pain and
opioid use and prevent further bone destruction, however, its use is limited because the
current workflow frequently requires one week for planning and two weeks for delivery.
Additionally, typical palliative radiation plans for osseous metastases lack conformality of
dose to the tumor volume, and therefore, result in radiation-induced toxicity to large
volumes of adjacent normal tissue. Recent software and hardware advancements provide the
opportunity to revolutionize the palliative treatment of osseous metastases. The
investigators propose to investigate a novel TomoTherapy-based workflow, called STAT RT,
which includes same day CT simulation, treatment planning, and quality assurance
measurements coupled with highly conformal treatment delivery for patients with osseous
metastases in a pilot clinical trial.

Objective: The overall goal of this STAT RT proposal is to develop a more rapid, convenient,
and effective palliative radiation approach for patients with osseous metastases that is
less toxic and less expensive than current treatment regimens. The investigators have
already optimized the conformality of TomoTherapy-based radiation doses for osseous
metastases, and the investigators have developed a STAT RT workflow that condenses standard
of care simulation, planning, quality assurance, and treatment delivery into 5-6 hours.
Additional optimization and integration of new radiation therapy computing processes will
allow for real time simulation, planning, and delivery via a novel Scan-Plan-Treat STAT RT
workflow that will ultimately require only 30 minutes. In this study the investigators will
evaluate the effectiveness of the current STAT RT workflow, and the investigators will
investigate techniques for further optimization that will be needed to create a 30 minute
Scan-Plan-Treat STAT RT workflow.

Primary Specific Aim/ Hypothesis: The investigators will quantify the time for pain
relief, amount of pain relief, opioid use reduction, functional scores, quality of life, and
satisfaction of patients treated with STAT RT for osseous metastases. The investigators
hypothesize that these patients will have rapid and significant pain relief, improved
quality of life, and high patient satisfaction.

Secondary Specific Aim/ Hypothesis: The investigators will optimize the integration of
commercially available and in-development software to develop the Scan-Plan-Treat STAT RT
workflow. Specifically, the investigators will A) optimize rigid and deformable
co-registration of pre-contoured diagnostic image sets to MVCT simulation scans and compare
the accuracy to the same pre-contoured diagnostic image sets co-registered to kilovoltage CT
(kVCT) simulation images and then kVCT simulation to MVCT scan co-registration, B) optimize
CT-detector-based exit dose measurement algorithms for quality assurance and compare to
standard of care phantom-based quality assurance, C) optimize the accuracy of an in-house
real time infrared tracking system for intrafractional patient position monitoring to ensure
accurate patient treatment. The investigators hypothesize that these new components will
provide effective and efficient methods for treatment planning, quality assurance, and
patient position monitoring that can be used in a future 30 minute Scan-Plan-Treat STAT RT

Study design: The investigators will recruit 30 cancer patients with 1-3 painful osseous
metastatic lesions (target sites) who are candidates for palliative radiation therapy.
Patients will receive 1-5 fractions of 5-8 Gray (Gy) (minimum biologic effective dose of 25
Gy) of conformal radiation therapy delivered to the target sites via the Helical TomoTherapy
system using the STAT RT workflow. 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. Using validated surveys the investigators will record patient
pain, analgesic use, function, quality of life, and patient satisfaction prior to treatment
and at 1 week, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months after therapy.
Radiation-induced treatment related toxicities will be captured during treatment and at the
above time points.

Inclusion Criteria:

- 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

- 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

- 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).

- 18 years of age or older.

- Life expectancy > 12 weeks.

- Able and willing to answer simple survey questionnaires.

- Able and willing to keep a logbook of analgesic use (with or without assistance).

- Willing to return to clinic for follow-up visits after first treatment.

- Signed study-specific informed consent form

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain relief as defined by the International Bone Metastases Consensus Group

Outcome Description:

Estimate the response to palliative radiation as defined by International Bone Metastases Consensus Group using the Brief Pain Inventory (BPI) and Oral Morphine Equivalent Doses (OMED) to categorize into Complete Response, Partial Response, Pain Progression, and Stable Pain after receiving treatment via the STAT RT workflow. Pain will be assessed within 7 days before the first treatment, at Week1, Week4, Week8, Week12, 6-months, and 12-months.

Outcome Time Frame:

Up to 12 months after treatment

Safety Issue:


Principal Investigator

Paul W Read, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia


United States: Institutional Review Board

Study ID:




Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Bone Metastases
  • Metastatic bone disease
  • Bone metastases
  • Radiation therapy
  • TomoTherapy
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases



University of VirginiaCharlottesville, Virginia  22908