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

Sponsor

NRG Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT02206334

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

93.6

Actual Duration (Months)

0.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Radiation: Stereotactic Body Radiation Therapy (SBRT)	Phase 1

Detailed Description

PRIMARY OBJECTIVES:

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:

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.
To estimate the rates of long-term adverse events occurring up to 2 years from the end of SBRT.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

May 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Radiation: Stereotactic Body Radiation Therapy (SBRT) Undergo SBRT Other Names: Stereotactic External Beam Irradiation stereotactic external-beam radiation therapy Stereotactic Radiation Therapy stereotactic radiosurgery Stereotactic Radiotherapy stereotaxic radiation therapy stereotaxic radiosurgery SBRT

Arm

Intervention/Treatment

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.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Undergo SBRT

Other Names:

Stereotactic External Beam Irradiation

stereotactic external-beam radiation therapy

Stereotactic Radiation Therapy

stereotactic radiosurgery

Stereotactic Radiotherapy

stereotaxic radiation therapy

stereotaxic radiosurgery

SBRT

Outcome Measures

Primary Outcome Measures

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 [Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment]
Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.

Secondary Outcome Measures

Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0 [Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration]
Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0 [Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment]
Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	United States	35233
2	Arizona Center for Cancer Care-Peoria	Peoria	Arizona	United States	85381
3	Banner University Medical Center - Tucson	Tucson	Arizona	United States	85719
4	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
5	UC San Diego Moores Cancer Center	La Jolla	California	United States	92093
6	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
7	Sutter Medical Center Sacramento	Sacramento	California	United States	95816
8	University of California Davis Comprehensive Cancer Center	Sacramento	California	United States	95817
9	University of Colorado Hospital	Aurora	Colorado	United States	80045
10	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
11	University of Florida Health Science Center - Gainesville	Gainesville	Florida	United States	32610
12	University of Florida Health Science Center - Jacksonville	Jacksonville	Florida	United States	32209
13	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	United States	33136
14	Grady Health System	Atlanta	Georgia	United States	30303
15	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
16	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	United States	30322
17	Northwest Community Hospital	Arlington Heights	Illinois	United States	60005
18	Northwestern University	Chicago	Illinois	United States	60611
19	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
20	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
21	Loyola University Medical Center	Maywood	Illinois	United States	60153
22	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
23	Memorial Medical Center	Springfield	Illinois	United States	62781
24	Southwest Illinois Health Services LLP	Swansea	Illinois	United States	62226
25	Saint Vincent Anderson Regional Hospital/Cancer Center	Anderson	Indiana	United States	46016
26	Parkview Hospital Randallia	Fort Wayne	Indiana	United States	46805
27	IU Health Methodist Hospital	Indianapolis	Indiana	United States	46202
28	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
29	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242
30	Ascension Via Christi Hospitals Wichita	Wichita	Kansas	United States	67214
31	University of Kentucky/Markey Cancer Center	Lexington	Kentucky	United States	40536
32	The James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky	United States	40202
33	University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
34	UM Upper Chesapeake Medical Center	Bel Air	Maryland	United States	21014
35	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889-5600
36	Boston Medical Center	Boston	Massachusetts	United States	02118
37	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
38	GenesisCare USA - Clarkston	Clarkston	Michigan	United States	48346
39	Henry Ford Hospital	Detroit	Michigan	United States	48202
40	GenesisCare USA - Farmington Hills	Farmington Hills	Michigan	United States	48334
41	McLaren Cancer Institute-Flint	Flint	Michigan	United States	48532
42	McLaren Cancer Institute-Macomb	Mount Clemens	Michigan	United States	48043
43	McLaren Cancer Institute-Northern Michigan	Petoskey	Michigan	United States	49770
44	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
45	GenesisCare USA - Troy	Troy	Michigan	United States	48098
46	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan	United States	48322
47	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
48	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
49	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
50	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
51	Virtua Memorial	Mount Holly	New Jersey	United States	08060
52	Cooper CyberKnife Center	Mount Laurel	New Jersey	United States	08054
53	Community Medical Center	Toms River	New Jersey	United States	08755
54	Virtua Voorhees	Voorhees	New Jersey	United States	08043
55	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
56	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
57	Northwell Health/Center for Advanced Medicine	Lake Success	New York	United States	11042
58	University of Rochester	Rochester	New York	United States	14642
59	Duke University Medical Center	Durham	North Carolina	United States	27710
60	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
61	University of Cincinnati Cancer Center-UC Medical Center	Cincinnati	Ohio	United States	45219
62	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
63	University of Cincinnati Cancer Center-West Chester	West Chester	Ohio	United States	45069
64	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon	United States	97210
65	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania	United States	19026
66	Reading Hospital	West Reading	Pennsylvania	United States	19611
67	Medical University of South Carolina	Charleston	South Carolina	United States	29425
68	Self Regional Healthcare	Greenwood	South Carolina	United States	29646
69	Ogden Regional Medical Center	Ogden	Utah	United States	84405
70	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	United States	84112
71	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
72	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
73	Zablocki Veterans Administration Medical Center	Milwaukee	Wisconsin	United States	53295
74	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
75	CHUM - Hopital Notre-Dame	Montreal	Quebec	Canada	H2L 4M1
76	CHUM - Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H2X 3E4
77	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
78	Kantonsspital Aarau	Aarau		Switzerland	5001