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.
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.
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
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There are 78 Locations for this study
Birmingham Alabama, 35233, United States
Peoria Arizona, 85381, United States
Tucson Arizona, 85719, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Sacramento California, 95816, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Fort Collins Colorado, 80524, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32209, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30303, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, 30322, United States
Arlington Heights Illinois, 60005, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Maywood Illinois, 60153, United States
Peoria Illinois, 61637, United States
Springfield Illinois, 62781, United States
Swansea Illinois, 62226, United States
Anderson Indiana, 46016, United States
Fort Wayne Indiana, 46805, United States
Indianapolis Indiana, 46202, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21201, United States
Bel Air Maryland, 21014, United States
Bethesda Maryland, 20889, United States
Boston Massachusetts, 02118, United States
Ann Arbor Michigan, 48109, United States
Clarkston Michigan, 48346, United States
Detroit Michigan, 48202, United States
Farmington Hills Michigan, 48334, United States
Flint Michigan, 48532, United States
Mount Clemens Michigan, 48043, United States
Petoskey Michigan, 49770, United States
Pontiac Michigan, 48341, United States
Troy Michigan, 48098, United States
West Bloomfield Michigan, 48322, United States
Coon Rapids Minnesota, 55433, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Mount Holly New Jersey, 08060, United States
Mount Laurel New Jersey, 08054, United States
Toms River New Jersey, 08755, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87102, United States
Bronx New York, 10467, United States
Lake Success New York, 11042, United States
Rochester New York, 14642, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43210, United States
West Chester Ohio, 45069, United States
Portland Oregon, 97210, United States
Drexel Hill Pennsylvania, 19026, United States
West Reading Pennsylvania, 19611, United States
Charleston South Carolina, 29425, United States
Greenwood South Carolina, 29646, United States
Ogden Utah, 84405, United States
Salt Lake City Utah, 84112, United States
La Crosse Wisconsin, 54601, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
Edmonton Alberta, T6G 1, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H2X 3, Canada
Montreal Quebec, H3T 1, Canada
Aarau , 5001, Switzerland
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