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

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ClinicalTrials.gov Identifier: NCT03523351
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumors of Metastatic Disease Radiation: Radiation Therapy Drug: Systemic Therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of Early, Upfront Palliative Radiation Therapy Versus Standard of Care for Patients With Highest Risk Asymptomatic or Minimally Symptomatic Bone Metastases
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. number of patients who have skeletal related events (SREs) [ Time Frame: 2 years ]
    which will be defined as pathological fractures, spinal cord compression, or palliative radiotherapy and orthopedic surgery to bone.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523351


Contacts
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Contact: Erin Gillespie, MD 212-639-6478 gillespe@mskcc.org
Contact: T. Jonathan Yang, MD, PhD 212-639-8157 yangt@mskcc.org

Locations
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United States, Florida
Baptist Alliance Miami Cancer Institute Recruiting
Miami, Florida, United States, 33143
Contact: Rupesh Kotecha, MD    786-596-2000      
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Erin Gillespie, MD    212-639-6478      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Erin Gillespie, MD    212-639-6478      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Erin Gillespie, MD    212-639-6478      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Erin Gillespie, MD    212-639-6478      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Erin Gillespie, MD    212-639-6478      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Erin S Gillespie, MD    212-639-6478      
Principal Investigator: Erin Gillespie, MD         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Erin Gillespie, MD    212-639-6478      
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Alyson McIntosh, MD    610-402-0700      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Erin Gillepsie, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03523351    
Other Study ID Numbers: 18-196
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Palliative Radiation
18-196
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes