Rapid Radiation Therapy for Painful Osseous Metastatic Di... | NCT01391234

NCT01391234

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Detailed Description

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 workflow.

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.

Arms/Interventions Module

Label	Type	Description	Intervention Names
STAT RT planning and delivery workflow	Experimental	single arm	Radiation: STAT RT planning and delivery workflow

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of Participants With Treatment Toxicity	Toxicity will be assessed by CTCAE Version 4.0 Toxicity will be assessed up to 12 months after treatment.	12 months after treatment
Number of Participants With an Improved Quality of Life Function Score at 1 Week Post Treatment

Eligibility Module

Eligibility Criteria

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 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).
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.

Name	Affiliation	Role
Paul W Read, MD	University of Virginia	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States

Arm/Group Information

ID	Title	Description
FG000	STAT RT Planning and Delivery Workflow	single arm 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	STAT RT Planning and Delivery Workflow	single arm 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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), or Stable Pain (no change in pain) at 12 months after receiving treatment via the STAT RT workflow.

Posted

Count of Participants

Participants

12 months after treatment

ID	Title	Description
OG000	STAT RT Planning and Delivery Workflow

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	STAT RT Planning and Delivery Workflow	single arm 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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Fatigue	General disorders		Non-systematic Assessment

Title	Organization	Phone	Extension	Email
Dr. Paul Read	University of Virginia Department of Radiation Oncology	(434) 924-5191		PWR3U@hscmail.mcc.virginia.edu

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 25, 2013	Jun 9, 2021	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Apr 8, 2014	Jun 9, 2021	ICF_001.pdf

ID	Term
D001847	Bone Diseases

ID	Term
D009140	Musculoskeletal Diseases

single arm

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.