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

NCT03523351 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 18-196
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of the study is to compare the outcome of patients who receive standard treatment versus those who receive preventative radiation and then standard treatment.

Conditions

Metastatic Solid Tumors of Metastatic Disease

Keywords

Palliative Radiation; 18-196

Outcome Measures

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.

  1 year

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Selective radiation to ≤5 highest risk bone metastases

EXPERIMENTAL

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

Radiation Therapy RADIATION

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.

Selective radiation to ≤5 highest risk bone metastases

Systemic Therapy DRUG

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.

Standard of care

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on imaging.
• Has high risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risks metastases are 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) and/or disease with posterior element involvement.
• ECOG performance status 0 - 2.
• Age ≥ 18 years.
• Able to provide informed consent.
• Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.

You may not qualify if:

• Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
• Serious medical co-morbidities precluding radiotherapy.
• Pregnant or lactating women.
• Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
• Leptomeningeal disease.
• Malignant pleural effusion.
• Absolute neutrophil count (ANC) \<1.0 K/mcL and platelet count \<50 K/mcL at time of enrollment.
• Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (9)

Baptist Alliance Miami Cancer Institute

Miami, Florida, 33143, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (2)

• Gillespie EF, Yang JC, Mathis NJ, Marine CB, White C, Zhang Z, Barker CA, Kotecha R, McIntosh A, Vaynrub M, Bartelstein MK, Mitchell A, Guttmann DM, Yerramilli D, Higginson DS, Yamada YJ, Kohutek ZA, Powell SN, Tsai J, Yang JT. Prophylactic Radiation Therapy Versus Standard of Care for Patients With High-Risk Asymptomatic Bone Metastases: A Multicenter, Randomized Phase II Clinical Trial. J Clin Oncol. 2024 Jan 1;42(1):38-46. doi: 10.1200/JCO.23.00753. Epub 2023 Sep 25.

  PMID: 37748124 DERIVED

• 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.

  PMID: 33203426 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Divya Yerramilli, MD
• Organization: Memorial Sloan Kettering Cancer Center

yerramid@mskcc.org

646-449-1931

Study Officials

• Divya Yerramilli, MD, MBE

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this trial patients will be divided into 2 cohorts. Patients in Cohort 1 will undergo standard of care therapy for bone metastases. Patients in Cohort 2 will undergo upfront RT to ≤5 highest risk bone metastases first followed by standard of care therapy.

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: May 1, 2018
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Locations

US (9)