Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis

NCT02699697 | Completed Results DMC FDA Device

• 4 other identifiers: IRB00037248NCI-2016-00204CCCWFU 01416P30CA012197
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Neoplasm; Pain; Metastatic Malignant Neoplasm in the Bone

Outcome Measures

Primary Outcomes (1)

• Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)

  The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.

  Up to 6 months post-treatment

Secondary Outcomes (7)

• Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale

  At 3 months and 6 months post-treatment

• Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use

  At 3 months and 6 months post-treatment

• Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)

  At 3 months and 6 months post-treatment

• Incidence of Adverse Events - Grade 3 or Higher

  Up to 6 months post-treatment

• Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18)

  At 3 months and 6 months post-treatment

Study Arms (2)

ARM I (palliative radiation therapy)

EXPERIMENTAL

Patients undergo 1 fraction of EBRT over 30 minutes.

Radiation: External Beam Radiation Therapy; Radiation: Palliative Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

ARM II (palliative radiation therapy)

EXPERIMENTAL

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

Radiation: External Beam Radiation Therapy; Radiation: Palliative Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

External Beam Radiation Therapy RADIATION

Undergo EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation

ARM I (palliative radiation therapy); ARM II (palliative radiation therapy)

Palliative Radiation Therapy RADIATION

Undergo EBRT

ARM I (palliative radiation therapy); ARM II (palliative radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

ARM I (palliative radiation therapy); ARM II (palliative radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

ARM I (palliative radiation therapy); ARM II (palliative radiation therapy)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Principal Investigator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

Doris.R.Brown@advocatehealth.org

3367135440

Study Officials

• Doris R Brown

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: May 1, 2016
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-11

Locations

US (1)