Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain

Browse trials for

• Neoplasm Metastasis 3,517

Keywords

• Palliative Radiation
• 18-196

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 78 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Study arms

• Active comparator
  Standard of care

  Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).

  Drug: Systemic Therapy

• Experimental
  Selective radiation to ≤5 highest risk bone metastases

  Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) \&/or disease with posterior element involvement.

  Radiation: Radiation Therapy

Interventions

• RadiationRadiation Therapy

  Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.

• DrugSystemic Therapy

  Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.

Primary outcomes

1. Number of Participants With Skeletal Related Events (SREs)

   which will be defined as pathological fractures, spinal cord compression, or palliative radiotherapy and orthopedic surgery to bone.

   Time frame: 1 year

Baseline characteristics

Publications

• Rosen DB, Benjamin CD, Yang JC, Doyle C, Zhang Z, Barker CA, Vaynrub M, Yang TJ, Gillespie EF. Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial. BMC Cancer. 2020 Nov 17;20(1):1115. doi: 10.1186/s12885-020-07591-w. PubMed 33203426 ↗

Related links

• Memorial Sloan Kettering Cancer Center ↗

Study documents

• Protocol and statistical analysis plan · Dec 5, 2022

Documents are hosted by the registry — open the source record to download them.