Clinical trial NCT03523351: Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Solid Tumors of Metastatic Disease
Keywords: Palliative Radiation
18-196
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Skeletal Related Events (SREs)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Alliance Miami Cancer Institute
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Divya Yerramilli, MD, MBE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.