A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms
2 other identifiers
interventional
167
1 country
3
Brief Summary
The goal of this clinical research study is to learn if 1 large dose of radiation therapy is better at controlling pain from cancer that has spread to the bones than 10 smaller doses of radiation. Researchers also want to learn if 1 large dose of radiation therapy can help decrease the use of drugs to control the pain, and if it can help to control the disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2014
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedStudy Start
First participant enrolled
August 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2020
CompletedResults Posted
Study results publicly available
November 8, 2021
CompletedNovember 8, 2021
October 1, 2021
6.1 years
June 9, 2014
August 20, 2021
October 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Intent- to- Treat Patients With Pain Response by Treatment
Evaluate single fraction stereotactic regimen for pain response in terms of time to failure. Pain response was defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. Time to failure was defined as the first occurrence of any of the following events: worsening in pain score by at least 2 categories by MDASI survey. Statistical tests in treatment group were based on the Wilcoxon rank sum test to compare changes in pain scores and analgesic use at each assessment point relative to baseline. Increases or decreases of 2 or more points on a scale of 0 to 10 indicated improving or worsening pain. Fisher exact tests were used to compare the distribution of pain responders (CR + PR) and nonresponders (PP + IR).
From date of registration until the date of first documented Pain failure or death from any cause, or lost to follow up, whichever came first, assessed up to 9 months
Number of Evaluable Participants With Pain Response by Treatment
Evaluate single fraction stereotactic regimen for pain response in terms of time to failure. Pain response was defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. Time to failure was defined as the first occurrence of any of the following events: worsening in pain score by at least 2 categories by MDASI survey. Complete response (CR) is a pain score of 0 at the treated site and no increase in analgesic. Partial response (PR): reduction in pain score of 2 or more points above baseline with no increase in analgesic. Pain progression (PP): Increases of 2 or more points on a scale of 0 to 10 or worsening pain. indeterminate response (IR): were all other responses.
From date of registration until the date of first documented Pain failure or death from any cause, or lost to follow up, whichever came first, assessed up to 9 months
Secondary Outcomes (1)
Number of Participants With Toxicity Associated With Treatment
From date of registration until the date of documented death from any cause, or lost to follow up, whichever came first, assessed up to 2 years.
Study Arms (2)
Hypofractionated Radiation Therapy
EXPERIMENTALParticipants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row. Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.
One Radiation Therapy Treatment
ACTIVE COMPARATOR12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV). Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.
Interventions
Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row.
12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV).
Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.
Eligibility Criteria
You may qualify if:
- Patients with a pathologic diagnosis of malignancy
- Patients with any radiographic evidence of bone metastases, including plain x-ray, bone scan, computed tomography (CT) scan, magnetic resonance imaging (MRI), or positron emission tomography (PET) scan
- Patients with pain or dysaesthesia
- Patients with a life expectancy of more than 3 months
- Patients able to complete pain assessment and quality of life surveys
- Patients with multiple osseous sites are eligible; however should not treat more than 3 separate radiation treatment fields concurrently.
- Patients with surgery for osseous metastases are allowed.
You may not qualify if:
- Patients with prior radiation therapy to the treatment site
- Patients with a current, untreated spinal cord compression
- Patients with a radiographic or pathologic fracture to the treatment site
- Patients with painful metastases to hands and feet that need to be radiated on protocol
- Patients previously treated with radioactive isotope (e.g. Sr89) within 30 days of randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey, 08043, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Nguyen QN, Chun SG, Chow E, Komaki R, Liao Z, Zacharia R, Szeto BK, Welsh JW, Hahn SM, Fuller CD, Moon BS, Bird JE, Satcher R, Lin PP, Jeter M, O'Reilly MS, Lewis VO. Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy for Pain Relief in Patients With Predominantly Nonspine Bone Metastases: A Randomized Phase 2 Trial. JAMA Oncol. 2019 Jun 1;5(6):872-878. doi: 10.1001/jamaoncol.2019.0192.
PMID: 31021390DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Quynh-Nhu Nguyen, MD,Associate Professor, Radiation Oncology Department
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Quynh-nhu Nguyen, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2014
First Posted
June 13, 2014
Study Start
August 6, 2014
Primary Completion
September 2, 2020
Study Completion
September 2, 2020
Last Updated
November 8, 2021
Results First Posted
November 8, 2021
Record last verified: 2021-10