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



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Lung Cancer, Prostate Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:August 2014
End Date:February 2023

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

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.

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.

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
We found this trial at
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Iowa City, Iowa 52242
Principal Investigator: Mark C. Smith
Phone: 800-237-1225
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1500 E Duarte Rd
Duarte, California 91010
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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655 West 8th Street
Jacksonville, Florida 32209
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Yuhchyau Chen
Phone: 585-341-8113
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Anderson, Indiana 46016
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Arlington Heights, Illinois 60005
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Atlanta, Georgia 30303
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, Georgia 30322
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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Bel Air, Maryland 21014
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8901 Rockville Pike
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(301) 295-4000
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Birmingham, Alabama 35233
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Boston, Massachusetts 02118
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Bronx, New York 10467
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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303 East Superior Street
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5841 S Maryland Ave
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1-773-702-6180
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Cincinnati, Ohio 45219
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4050 Coon Rapids Blvd NW
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2300 N Edward St
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1200 Pleasant St
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2799 W Grand Blvd
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2301 Erwin Rd
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Edmonton, Alberta
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28595 Orchard Lake Road
Farmington Hills, Michigan 48334
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Flint, Michigan 48532
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1024 S Lemay Ave
Fort Collins, Colorado 80524
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2200 Randallia Drive
Fort Wayne, Indiana 46805
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1600 Southwest Archer Road
Gainesville, Florida 32610
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Indianapolis, Indiana 46202
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La Crosse, Wisconsin
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3855 Health Sciences Dr,
La Jolla, California 92093
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450 Lakeville Road
Lake Success, New York 11042
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Lexington, Kentucky
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
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2160 South 1st Avenue
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
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Mount Clemens, Michigan 48043
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5475 South 500 East
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Peoria, Illinois 61637
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1015 NW 22nd Ave
Portland, Oregon 97210
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Sacramento, California 95819
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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701 N 1st St
Springfield, Illinois 62781
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7 Executive Woods Court
Swansea, Illinois 62226
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Toms River, New Jersey 08755
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4550 Investment Drive
Troy, Michigan 48098
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West Chester, Ohio 45069
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300 South 6th Avenue
West Reading, Pennsylvania 19611
(610) 988-8000
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Reading Hospital At Reading Health System, advancing your health and wellness is our mission. When...
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929 N St Francis St
Wichita, Kansas 67214
(316) 268-5775
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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