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A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms

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ClinicalTrials.gov Identifier: NCT02163226
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Bone Metastases Radiation: Hypofractionated Radiation Treatment Radiation: One Radiation Treatment Behavioral: Questionnaire Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms
Actual Study Start Date : August 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: 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.
Radiation: 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.
Other Name: XRT

Behavioral: 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 Name: Survey

Active Comparator: 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.
Radiation: 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).
Other Name: XRT

Behavioral: 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 Name: Survey




Primary Outcome Measures :
  1. Treatment Failure [ Time Frame: 3 months ]
    Evaluation of hypo-fractionated regimen for pain control in terms of time to failure defined as the first occurrence of any of the following events: Worsening in pain score by at least one category, ≥ 50% increase in dose of opioid/narcotic medication, re-irradiation, radiographic disease progression or development of pathologic fracture from disease progression.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163226


Locations
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United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
United States, New Jersey
MD Anderson Cancer Center at Cooper
Voorhees, New Jersey, United States, 08043
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Quynh-nhu Nguyen, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02163226     History of Changes
Other Study ID Numbers: 2013-0640
NCI-2014-01482 ( Registry Identifier: NCI CTRP )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Keywords provided by M.D. Anderson Cancer Center:
Bone metastases
Hypofractionated Radiation Therapy
Standard Radiation Therapy
XRT
Pain control
Palliation of symptoms
Questionnaire
Survey
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases