Clinical trial NCT02163226: A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms
Official title: A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bone Metastases
Keywords: Bone metastases
Hypofractionated Radiation Therapy
Standard Radiation Therapy
XRT
Pain control
Palliation of symptoms
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Study Groups:

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with a pathologic diagnosis of malignancy
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:

1. Patients with prior radiation therapy to the treatment site
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

Primary outcomes:
measure: Number of Intent- to- Treat Patients With Pain Response by Treatment
timeFrame: 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
measure: Number of Evaluable Participants With Pain Response by Treatment
timeFrame: 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:
measure: Number of Participants With Toxicity Associated With Treatment
timeFrame: 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.
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Voorhees
country: United States
facility: MD Anderson Cancer Center at Cooper
state: New Jersey
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Quynh-nhu Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.