Clinical trial NCT02206334: Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
Official title: A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Male Breast Carcinoma
Prostate Adenocarcinoma
Recurrent Breast Carcinoma
Recurrent Non-Small Cell Lung Carcinoma
Recurrent Prostate Carcinoma
Stage IV Breast Cancer
Stage IV Non-Small Cell Lung Cancer
Stage IV Prostate Cancer
Lead sponsor: NRG Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting.

SECONDARY OBJECTIVES:

I. To estimate rates of \>= grade 3 Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly, probably, or definitely related to treatment and which occurs within 6 months from the start of SBRT to multiple metastases.

II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of SBRT.

III. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.

OUTLINE:

Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.

After completion of study treatment, patients are followed up at 35-45 days and then every 3 months for 2 years.

Eligibility criteria: Inclusion Criteria:

* Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR metastatic adenocarcinoma of the prostate; the sites of allowed metastases are: peripheral lung, central lung, mediastinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic

  * NOTE: after the required number of evaluable patients have been accrued for a given dose level, the accrual for that metastatic location will be temporarily suspended while the safety of that dose level is assessed; a patient can only be entered onto the trial if all of their metastatic locations are open to accrual (e.g. if central lung is temporarily suspended for safety assessment and the patient has a central lung metastases, regardless of other metastases, they cannot enroll until the safety of dose to central lung is determined)
* Primary tumor site without progression at registration
* All metastases not resected must be amenable to SBRT
* The patient must meet ONE of the three following criteria:

  * 3-4 radiographically distinct metastases of any distribution in the allowed anatomical sites OR
  * 2 radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR
  * 3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s) having been surgically removed
* Evaluation by a radiation oncologist within 45 days prior to study registration
* Evaluation by a medical oncologist within 45 days prior to study registration
* The following imaging workup to document metastases within 45 days prior to study registration:

  * Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT
* History/physical examination within 45 days prior to study registration
* Zubrod performance status =\< 2 within 45 days prior to study registration
* Age \>= 18 years
* Absolute neutrophil count (ANC) \>= 500 cells/mm\^3
* Platelets \>= 50,000 /mm\^3
* Hemoglobin \>= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
* If liver metastases present, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be \< 3 x upper limit of normal (ULN)
* Patient must provide study specific informed consent prior to study entry
* For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration

Exclusion Criteria:

* Progression of primary tumor site (breast, prostate, or lung) at time of registration
* Metastases with indistinct borders making targeting not feasible
* Known brain metastases
* Prior palliative radiotherapy to metastases
* Metastases located within 3 cm of the previously irradiated structures:

  * Spinal cord previously irradiated to \> 40 Gy (delivered in =\< 3 Gy/fraction)
  * Brachial plexus previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction)
  * Small intestine, large intestine, or stomach previously irradiated to \> 45 Gy (delivered in =\< 3 Gy/fraction)
  * Brain stem previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction)
  * Whole lung previously irradiated with prior volume 20 Gy (V20Gy) \> 30% (delivered in =\< 3 Gy/fraction)
  * Primary tumor irradiated with SBRT
  * Metastasis irradiated with SBRT
* Severe, active co-morbidity, defined as follows:

  * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
  * Transmural myocardial infarction within the last 6 months prior to registration
  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
  * Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
  * Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD) 4 count \< 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
  * End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
* Pregnancy or women of childbearing potential not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment

Primary outcomes:
measure: Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT
timeFrame: Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment
Secondary outcomes:
measure: Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
timeFrame: Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration
measure: Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0
timeFrame: Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Cancer Center
state: Alabama
city: Peoria
country: United States
facility: Arizona Center for Cancer Care-Peoria
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson
state: Arizona
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center Sacramento
state: California
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Health Science Center - Gainesville
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Science Center - Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Swansea
country: United States
facility: Southwest Illinois Health Services LLP
state: Illinois
city: Anderson
country: United States
facility: Saint Vincent Anderson Regional Hospital/Cancer Center
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Hospital Randallia
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa/Holden Comprehensive Cancer Center
state: Iowa
city: Wichita
country: United States
facility: Ascension Via Christi Hospitals Wichita
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky/Markey Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: The James Graham Brown Cancer Center at University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland/Greenebaum Cancer Center
state: Maryland
city: Bel Air
country: United States
facility: UM Upper Chesapeake Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Clarkston
country: United States
facility: GenesisCare USA - Clarkston
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Farmington Hills
country: United States
facility: GenesisCare USA - Farmington Hills
state: Michigan
city: Flint
country: United States
facility: McLaren Cancer Institute-Flint
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Cancer Institute-Macomb
state: Michigan
city: Petoskey
country: United States
facility: McLaren Cancer Institute-Northern Michigan
state: Michigan
city: Pontiac
country: United States
facility: Saint Joseph Mercy Oakland
state: Michigan
city: Troy
country: United States
facility: GenesisCare USA - Troy
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Mount Holly
country: United States
facility: Virtua Memorial
state: New Jersey
city: Mount Laurel
country: United States
facility: Cooper CyberKnife Center
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Virtua Voorhees
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: Lake Success
country: United States
facility: Northwell Health/Center for Advanced Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Center-UC Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: West Chester
country: United States
facility: University of Cincinnati Cancer Center-West Chester
state: Ohio
city: Portland
country: United States
facility: Legacy Good Samaritan Hospital and Medical Center
state: Oregon
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenwood
country: United States
facility: Self Regional Healthcare
state: South Carolina
city: Ogden
country: United States
facility: Ogden Regional Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Zablocki Veterans Administration Medical Center
state: Wisconsin
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Montreal
country: Canada
facility: CHUM - Hopital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
Study officials:
affiliation: NRG Oncology
name: Steven Chmura
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chmura S, Winter KA, Robinson C, Pisansky TM, Borges V, Al-Hallaq H, Matuszak M, Park SS, Yi S, Hasan Y, Bazan J, Wong P, Yoon HA, Horton J, Gan G, Milano MT, Sigurdson ER, Moughan J, Salama JK, White J. Evaluation of Safety of Stereotactic Body Radiotherapy for the Treatment of Patients With Multiple Metastases: Findings From the NRG-BR001 Phase 1 Trial. JAMA Oncol. 2021 Jun 1;7(6):845-852. doi: 10.1001/jamaoncol.2021.0687.