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

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT02206334
Run by: NRG Oncology
People needed: 42
Starts: 2014-08-01
Expected to finish: 2022-05-20
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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