Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT02206334

Recruitment Status:

Completed

Sponsor:

NRG Oncology

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There are 78 Locations for this study

See Locations Near You

University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
Arizona Center for Cancer Care-Peoria
Peoria Arizona, 85381, United States
Banner University Medical Center - Tucson
Tucson Arizona, 85719, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Sutter Medical Center Sacramento
Sacramento California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States
University of Florida Health Science Center - Jacksonville
Jacksonville Florida, 32209, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States
Grady Health System
Atlanta Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northwest Community Hospital
Arlington Heights Illinois, 60005, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
OSF Saint Francis Medical Center
Peoria Illinois, 61637, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Southwest Illinois Health Services LLP
Swansea Illinois, 62226, United States
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson Indiana, 46016, United States
Parkview Hospital Randallia
Fort Wayne Indiana, 46805, United States
IU Health Methodist Hospital
Indianapolis Indiana, 46202, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Ascension Via Christi Hospitals Wichita
Wichita Kansas, 67214, United States
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville Kentucky, 40202, United States
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
UM Upper Chesapeake Medical Center
Bel Air Maryland, 21014, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
GenesisCare USA - Clarkston
Clarkston Michigan, 48346, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
GenesisCare USA - Farmington Hills
Farmington Hills Michigan, 48334, United States
McLaren Cancer Institute-Flint
Flint Michigan, 48532, United States
McLaren Cancer Institute-Macomb
Mount Clemens Michigan, 48043, United States
McLaren Cancer Institute-Northern Michigan
Petoskey Michigan, 49770, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
GenesisCare USA - Troy
Troy Michigan, 48098, United States
Henry Ford West Bloomfield Hospital
West Bloomfield Michigan, 48322, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Virtua Memorial
Mount Holly New Jersey, 08060, United States
Cooper CyberKnife Center
Mount Laurel New Jersey, 08054, United States
Community Medical Center
Toms River New Jersey, 08755, United States
Virtua Voorhees
Voorhees New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
Northwell Health/Center for Advanced Medicine
Lake Success New York, 11042, United States
University of Rochester
Rochester New York, 14642, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
University of Cincinnati Cancer Center-West Chester
West Chester Ohio, 45069, United States
Legacy Good Samaritan Hospital and Medical Center
Portland Oregon, 97210, United States
Delaware County Memorial Hospital
Drexel Hill Pennsylvania, 19026, United States
Reading Hospital
West Reading Pennsylvania, 19611, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Self Regional Healthcare
Greenwood South Carolina, 29646, United States
Ogden Regional Medical Center
Ogden Utah, 84405, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Zablocki Veterans Administration Medical Center
Milwaukee Wisconsin, 53295, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
CHUM - Hopital Notre-Dame
Montreal Quebec, H2L 4, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal Quebec, H2X 3, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Kantonsspital Aarau
Aarau , 5001, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT02206334

Recruitment Status:

Completed

Sponsor:


NRG Oncology

How clear is this clinincal trial information?

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