Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2025-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized phase II trial studies how well palliative radiation therapy works in reducing pain in patients with cancer that has spread from the original (primary) tumor to the bone (bone metastasis). Palliative radiation therapy using external beam radiation therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer

NCT00003162

Breast Cancer Metastatic Cancer Pain +1 more

COMPLETED PHASE3

Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases

NCT07202273

Bone Metastases

RECRUITING NA

Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

NCT05115331

Metastatic Bone Tumor

ACTIVE_NOT_RECRUITING PHASE3

Palliative Radiotherapy for Bone Metastases: Single Versus Multiple Fractions.

NCT00858741

Bone Metastases Pain

COMPLETED PHASE3

Phase 1/2 Study to Determine Optimal Dose for Treating Bone Metastases Using Novel STAT-RT Workflow

NCT02145286

Metastatic Bone Lesion

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To determine whether 8 gray (Gy) x 2 fractions results in lower re-treatment rates compared to 8 Gy x 1 fraction.

SECONDARY OBJECTIVES:

I. To determine whether 8 Gy x 2 fractions provides superior pain and narcotic relief compared to 8 Gy x 1 fraction.

II. To determine whether 8 Gy x 2 fractions is associated with improved quality of life compared to 8 Gy x 1 fraction.

III. To determine whether use of a bone strengthening agent is associated with improved pain relief, narcotic relief and re-treatment rates.

IV. To determine if 8 Gy x 2 fractions is associated with increased toxicity. V. To correlate patient satisfaction, perceived stress, and social support with treatment outcomes.

TERTIARY OBJECTIVES:

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo 1 fraction of external beam radiation therapy (EBRT) over 30 minutes.

ARM II: Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.

After completion of study treatment, patients are followed up at 30 days and at 3 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Neoplasm Metastatic Malignant Neoplasm in the Bone Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

External Beam Radiation Therapy

Undergo EBRT

Intervention Type RADIATION

Palliative Radiation Therapy

Undergo EBRT

Intervention Type RADIATION

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Definitive Radiation Therapy EBRT External Beam Radiotherapy External Beam RT external radiation External Radiation Therapy external-beam radiation Quality of Life Assessment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of cancer, not including multiple myeloma
* Radiographic evidence of bone metastases within 8 weeks of study; the patient must have pain which appears to be related to the radiographically documented metastasis in the opinion of the treating physician, and the decision has been made by the responsible clinician that a course of palliative external beam radiation therapy is appropriate treatment; multiple sites eligible if they can be included in no greater than 3 treatment sites
* Eligible treatment sites are:

* Weight bearing sites

* Pelvis (excluding pubis)
* Femur
* Sacrum and/or sacroiliac joints
* Tibia
* Non-weight bearing sites

* Up to 5 consecutive cervical, thoracic or lumbar vertebral bodies
* Lumbosacral spine
* Up to 3 consecutive ribs
* Humerus
* Fibula
* Radius ± ulna
* Clavicle
* Sternum
* Scapula
* Pubis If multiple sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur or tibia
* Pain score of at least 5 on a scale of 0 - 10 within a week of enrollment OR pain score \< 5 with \>= 60 mg of morphine (or equivalent) per day
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
* Negative pregnancy test at study registration
* Changes in systemic chemotherapy, hormonal therapy or the use of bisphosphonates for 4 weeks before and after the delivery of radiotherapy are allowed, but recording and accounting for this in the statistical analysis is required
* Life expectancy of at least 12 weeks as deemed by the treating oncologist
* Patients will be eligible for treatment of multiple osseous sites only if those sites can be included in no more than three treatment sites; for patients with painful metastases that are contiguous but do not fit into the definition of a site listed above, those patients will still be eligible but will be considered to have two treatment sites; for example, a patient with a lesion of T4, T7 and T9 would be eligible but would be considered as two treatment sites since more than five consecutive vertebral bodies would be treated; these lesions could be treated with one field, even though the treatment is coded as two sites

Exclusion Criteria

* Previous radiotherapy or palliative surgery to the painful site
* Metastases to the skull, hands, feet are not eligible treatment sites
* Spinal cord or cauda equine compression/effacement in vertebral metastases with neurological symptoms other than just pain

Eligible Sex

ALL

Accepts Healthy Volunteers

No