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

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206334
• Other study ID #: NRG-BR001
• Secondary ID: NCI-2014-00702NR
• Status: Completed
• Phase: Phase 1
• Start date: August 2014
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: NRG Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 20, 2022
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Male Breast Carcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• 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

Radiation:
• Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUM - Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	CHUM - Hopital Notre-Dame	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Switzerland	Kantonsspital Aarau	Aarau
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Saint Vincent Anderson Regional Hospital/Cancer Center	Anderson	Indiana
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland
United States	UM Upper Chesapeake Medical Center	Bel Air	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	University of Cincinnati Cancer Center-UC Medical Center	Cincinnati	Ohio
United States	GenesisCare USA - Clarkston	Clarkston	Michigan
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	GenesisCare USA - Farmington Hills	Farmington Hills	Michigan
United States	McLaren Cancer Institute-Flint	Flint	Michigan
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Parkview Hospital Randallia	Fort Wayne	Indiana
United States	University of Florida Health Science Center - Gainesville	Gainesville	Florida
United States	Self Regional Healthcare	Greenwood	South Carolina
United States	IU Health Methodist Hospital	Indianapolis	Indiana
United States	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	University of Florida Health Science Center - Jacksonville	Jacksonville	Florida
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Northwell Health/Center for Advanced Medicine	Lake Success	New York
United States	University of Kentucky/Markey Cancer Center	Lexington	Kentucky
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	The James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Zablocki Veterans Administration Medical Center	Milwaukee	Wisconsin
United States	McLaren Cancer Institute-Macomb	Mount Clemens	Michigan
United States	Virtua Memorial	Mount Holly	New Jersey
United States	Cooper CyberKnife Center	Mount Laurel	New Jersey
United States	Ogden Regional Medical Center	Ogden	Utah
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Arizona Center for Cancer Care-Peoria	Peoria	Arizona
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	McLaren Cancer Institute-Northern Michigan	Petoskey	Michigan
United States	Saint Joseph Mercy Oakland	Pontiac	Michigan
United States	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Sutter Medical Center Sacramento	Sacramento	California
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah
United States	Memorial Medical Center	Springfield	Illinois
United States	Southwest Illinois Health Services LLP	Swansea	Illinois
United States	Community Medical Center	Toms River	New Jersey
United States	GenesisCare USA - Troy	Troy	Michigan
United States	Banner University Medical Center - Tucson	Tucson	Arizona
United States	Virtua Voorhees	Voorhees	New Jersey
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan
United States	University of Cincinnati Cancer Center-West Chester	West Chester	Ohio
United States	Reading Hospital	West Reading	Pennsylvania
United States	Ascension Via Christi Hospitals Wichita	Wichita	Kansas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
NRG Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.	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
Secondary	Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0	Adverse events reported as being possibly, probably, or definitely related to protocol treatment.	Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration
Secondary	Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0	Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.	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