A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms
NCT ID: NCT02163226
Last Updated: 2021-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
167 participants
INTERVENTIONAL
2014-08-06
2020-09-02
Brief Summary
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Detailed Description
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If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to either group.
If you are in Group 1, you will receive 1 radiation treatment a day for 10 days in a row (not counting weekends or holidays). You will receive a higher total dose of radiation than Group 2.
If you are in Group 2, you will receive 1 radiation treatment given on 1 day.
Radiation Therapy:
You will lie on a table for the radiation treatment(s). Each treatment will last about 30 minutes.
Length of Treatment:
You may receive 1 or 10 radiation treatments, depending on which group you are in. You will no longer be able to receive radiation therapy if intolerable side effects occur or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
Follow-Up Visits:
At Months 3, 6, 9, 12 and every 3 to 6 months after the start of radiation therapy, you will have x-rays, a bone scan, CT scan, or MRI to check the status of the disease.
At Months 3, 4, and 6 and then every 3 months after that for at least 3 years, you will complete the questionnaires about the pain, your pain relief, and your quality of life. The questionnaires can be filled out at a clinic visit or sent back in the mail.
This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. It is investigational to compare the number and size of radiation doses.
Up to 300 participants will take part in this multicenter study. Up to 300 participants will be enrolled at MD Anderson.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypofractionated Radiation Therapy
Participants 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.
Hypofractionated Radiation Treatment
Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row.
Questionnaire
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
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.
One Radiation Treatment
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
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
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Hypofractionated Radiation Treatment
Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row.
One Radiation Treatment
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. Patients with pain or dysaesthesia
4. Patients with a life expectancy of more than 3 months
5. Patients able to complete pain assessment and quality of life surveys
6. Patients with multiple osseous sites are eligible; however should not treat more than 3 separate radiation treatment fields concurrently.
7. Patients with surgery for osseous metastases are allowed.
Exclusion Criteria
2. Patients with a current, untreated spinal cord compression
3. Patients with a radiographic or pathologic fracture to the treatment site
4. Patients with painful metastases to hands and feet that need to be radiated on protocol
5. Patients previously treated with radioactive isotope (e.g. Sr89) within 30 days of randomization
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Quynh-nhu Nguyen, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2014-01482
Identifier Type: REGISTRY
Identifier Source: secondary_id
2013-0640
Identifier Type: -
Identifier Source: org_study_id