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NCT02206334

PHASE1

Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2014-08

Completion Date

2022-05-20

Last Updated

2026-06-25

Healthy Volunteers

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

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Undergo SBRT

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

Locations (78)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Northwest Community Hospital

Arlington Heights, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Ascension Saint Vincent Anderson

Anderson, Indiana, United States

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Michigan Healthcare Professionals Troy

Troy, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Virtua Memorial

Mount Holly, New Jersey, United States

Cooper CyberKnife Center

Mount Laurel, New Jersey, United States

Community Medical Center

Toms River, New Jersey, United States

Virtua Voorhees

Voorhees Township, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

University of Rochester

Rochester, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Self Regional Healthcare

Greenwood, South Carolina, United States

Ogden Regional Medical Center

Ogden, Utah, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Kantonsspital Aarau

Aarau, Switzerland

Clinical Research Directory

Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (78)