Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
Male Breast Carcinoma, Prostate Adenocarcinoma, Recurrent Breast Carcinoma
About this trial
This is an interventional treatment trial for Male Breast Carcinoma
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
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Arizona Center for Cancer Care-Peoria
- Banner University Medical Center - Tucson
- City of Hope Comprehensive Cancer Center
- UC San Diego Moores Cancer Center
- USC / Norris Comprehensive Cancer Center
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- University of Colorado Hospital
- Poudre Valley Hospital
- University of Florida Health Science Center - Gainesville
- University of Florida Health Science Center - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Grady Health System
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Northwest Community Hospital
- Northwestern University
- University of Chicago Comprehensive Cancer Center
- Decatur Memorial Hospital
- Loyola University Medical Center
- OSF Saint Francis Medical Center
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Saint Vincent Anderson Regional Hospital/Cancer Center
- Parkview Hospital Randallia
- IU Health Methodist Hospital
- Iowa Methodist Medical Center
- University of Iowa/Holden Comprehensive Cancer Center
- Ascension Via Christi Hospitals Wichita
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of Louisville
- University of Maryland/Greenebaum Cancer Center
- UM Upper Chesapeake Medical Center
- Walter Reed National Military Medical Center
- Boston Medical Center
- University of Michigan Comprehensive Cancer Center
- GenesisCare USA - Clarkston
- Henry Ford Hospital
- GenesisCare USA - Farmington Hills
- McLaren Cancer Institute-Flint
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- GenesisCare USA - Troy
- Henry Ford West Bloomfield Hospital
- Mercy Hospital
- Mayo Clinic in Rochester
- Washington University School of Medicine
- University of Nebraska Medical Center
- Virtua Memorial
- Cooper CyberKnife Center
- Community Medical Center
- Virtua Voorhees
- University of New Mexico Cancer Center
- Montefiore Medical Center - Moses Campus
- Northwell Health/Center for Advanced Medicine
- University of Rochester
- Duke University Medical Center
- Wake Forest University Health Sciences
- University of Cincinnati Cancer Center-UC Medical Center
- Ohio State University Comprehensive Cancer Center
- University of Cincinnati Cancer Center-West Chester
- Legacy Good Samaritan Hospital and Medical Center
- Delaware County Memorial Hospital
- Reading Hospital
- Medical University of South Carolina
- Self Regional Healthcare
- Ogden Regional Medical Center
- Huntsman Cancer Institute/University of Utah
- Gundersen Lutheran Medical Center
- Medical College of Wisconsin
- Zablocki Veterans Administration Medical Center
- Cross Cancer Institute
- CHUM - Hopital Notre-Dame
- CHUM - Centre Hospitalier de l'Universite de Montreal
- Jewish General Hospital
- Kantonsspital Aarau
Arms of the Study
Arm 1
Experimental
Stereotactic Body Radiation Therapy (SBRT)
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.