RECRUITING

Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases

Description

This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.

Study Overview

Study Details

Study overview

This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.

Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)

Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases

Condition
Metastatic Malignant Neoplasm in the Bone
Intervention / Treatment

-

Contacts and Locations

Fairbanks

Fairbanks Memorial Hospital, Fairbanks, Alaska, United States, 99701

Phoenix

Cancer Center at Saint Joseph's, Phoenix, Arizona, United States, 85004

Antioch

Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States, 94531

Arroyo Grande

Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, California, United States, 93420

Auburn

Sutter Auburn Faith Hospital, Auburn, California, United States, 95602

Auburn

Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, United States, 95603

Bakersfield

AIS Cancer Center at San Joaquin Community Hospital, Bakersfield, California, United States, 93301

Berkeley

Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States, 94704

Burlingame

Mills-Peninsula Medical Center, Burlingame, California, United States, 94010

Cameron Park

Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States, 95682

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * • Patients with polymetastatic cancer defined as more than 5 sites of radiographically-evident systemic metastatic disease (excluding intracranial disease)
  • * "High-risk" asymptomatic bone metastasis (Brief Pain Inventory \[BPI\] score of \< 5 on the "maximum" pain item) defined as fulfilling at least one of the following four high-risk criteria:
  • * Bulky site of disease in bone ( ≥ 2 cm);
  • * Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints;
  • * Disease in long bones occupying up to 2/3 of the cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges); and/or
  • * Disease in junctional spine (C7-T1, T12-L1, L5-S1) and/or disease with posterolateral element (pedicles and/or facet joints) involvement
  • * NOTE: Sternum, rib, and scapula are defined as flat bones so lesions in these locations would only be included if bulky
  • * Patients with any solid tumor type (excluding multiple myeloma)
  • * Patients must have systemic disease evaluation through standard of care diagnostic imaging, including either CT chest/abdomen/pelvis or body positron emission tomography (PET)/CT, with radiology report available
  • * Patients with treated brain metastases and no known leptomeningeal disease are eligible if these lesions have been treated prior to enrollment
  • * Age ≥ 18
  • * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status (KPS) ≥ 60
  • * No previous radiotherapy to the intended enrolled sites of disease
  • * No epidural spinal cord compression (ESCC) ≥ grade 1c (defined as deformation of the thecal sac with spinal cord abutment) at the enrolled bone metastasis(es)
  • * No prior fracture at the enrolled bone metastasis(es)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NRG Oncology,

Study Record Dates

2028-10-01