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

Information source: NRG Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: 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

Intervention: Stereotactic Radiosurgery (Radiation)

Phase: Phase 1

Status: Recruiting

Sponsored by: NRG Oncology

Official(s) and/or principal investigator(s):
Steven Chmura, Principal Investigator, Affiliation: NRG Oncology


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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT

Secondary outcome:

Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0

Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0

Detailed 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

- Brachial plexus previously irradiated to > 50 Gy

- Small intestine, large intestine, or stomach previously irradiated to > 45 Gy

- Brain stem previously irradiated to > 50 Gy

- Lung previously irradiated with prior volume 20 Gy (V20Gy) > 30%

- 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

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Jennifer F. De Los Santos, Phone: 888-823-5923, Email: ctsucontact@westat.com
Jennifer F. De Los Santos, Principal Investigator

University of California Davis Comprehensive Cancer Center, Sacramento, California 95817, United States; Recruiting
Megan E. Daly, Phone: 916-734-3089
Megan E. Daly, Principal Investigator

University of Florida, Gainesville, Florida 32610, United States; Recruiting
Roi Dagan, Phone: 877-686-6009
Roi Dagan, Principal Investigator

Emory University Hospital Midtown, Atlanta, Georgia 30308, United States; Recruiting
Pretesh R. Patel, Phone: 404-778-1868
Pretesh R. Patel, Principal Investigator

Emory University/Winship Cancer Institute, Atlanta, Georgia 30322, United States; Recruiting
Pretesh R. Patel, Phone: 404-778-1868
Pretesh R. Patel, Principal Investigator

Northwest Community Hospital, Arlington Heights, Illinois 60005, United States; Recruiting
Stephen S. Nigh, Phone: 847-618-4968
Stephen S. Nigh, Principal Investigator

University of Chicago Comprehensive Cancer Center, Chicago, Illinois 60637, United States; Recruiting
Steven J. Chmura, Phone: 773-834-7424
Steven J. Chmura, Principal Investigator

The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky 40202, United States; Recruiting
Neal E. Dunlap, Phone: 866-530-5516
Neal E. Dunlap, Principal Investigator

Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting
Eleanor M. Walker, Phone: 313-916-1784
Eleanor M. Walker, Principal Investigator

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Joseph K. Salama, Phone: 888-275-3853
Joseph K. Salama, Principal Investigator

Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210, United States; Recruiting
Jose G. Bazan, Phone: 800-293-5066, Email: Jamesline@osumc.edu
Jose G. Bazan, Principal Investigator

Reading Hospital, West Reading, Pennsylvania 19611, United States; Recruiting
Michael L. Haas, Phone: 610-988-9323
Michael L. Haas, Principal Investigator

CHUM - Hopital Notre-Dame, Montreal, Quebec H2L 4M1, Canada; Recruiting
Philip Wong, Phone: 514-890-8000ext23611, Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca
Philip Wong, Principal Investigator

Additional Information

Starting date: August 2014
Last updated: March 5, 2015

Page last updated: August 23, 2015

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