Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

Sponsors

Lead Sponsor: NRG Oncology

Collaborator: National Cancer Institute (NCI)

Source NRG Oncology
Brief Summary

This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R) II. To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS). (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate treated metastasis control according to tumor receptor status (estrogen receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor [HER]-2), use of chemotherapy, surgery vs. ablative therapy, and solitary metastasis vs. 2 metastasis (may expand to >= 2 to =< 4 following completion of a Phase I trial).

II. To evaluate whether the addition of ablative metastasis directed therapy significantly reduces the number of distant recurrences (new metastases) in patients who progress according to tumor receptor status (ER, PR, HER-2); use of chemotherapy, and solitary metastasis vs. 2 metastases (may expand to >= 2 to =< 4 following completion of the Phase I NRG-BR001 trial).

III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy alone.

IV. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout the radiation therapy processes, including imaging, simulation, target and critical structure definition, treatment planning, image guidance, and delivery.

TERTIARY OBJECTIVES:

I. To determine whether < 5 circulating tumor cells (CTCs) (per 7.5 ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer.

II. To determine whether < 5 CTCs (per 7.5 ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer.

III. To determine whether eliminating CTCs (0/7.5 ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS.

IV. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS.

V. To store material for retrospective analysis of circulating tumor deoxyribonucleic acid (ctDNA).

VI. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician.

ARM 2: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician. Patients also undergo stereotactic radiosurgery in 1, 3, or 5 fractions within 3 weeks and/or surgery at the discretion of the treating physician.

ARM 1: Patients are followed every 3 months from randomization to 2 years. ARM 2: Patients are followed 25-35 days post-ablation, every 3 months from randomization to 2 years, and then yearly thereafter.

Overall Status Recruiting
Start Date December 24, 2014
Completion Date December 31, 2027
Primary Completion Date December 31, 2022
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Progression-free survival (failure: progression or death due to any cause) (Phase II-R) From the date of randomization to the date of first PFS failure or last follow-up; assessed up to 3 years
Overall survival (failure: death due to any cause) (Phase III) From the date of randomization to the date of death or last follow-up; assessed up to 8 years
Secondary Outcome
Measure Time Frame
Appearance of new metastases From the date of randomization to the date of the first appearance of any new metastases; assessed up to 8 years
Incidence of adverse events graded according to National Cancer Institute CTCAE version 4 From the date of randomization to the date of death or last follow-up; assessed up to 2 years
Initial presence of CTCs in blood samples Baseline
Presence of CTCs after treatment in blood samples Up to 3 months
Change in CTC count in blood samples Baseline to up to 3 months
Levels of ctDNA in plasma samples Up to 3 months
Enrollment 402
Condition
Intervention

Intervention Type: Radiation

Intervention Name: Stereotactic Radiosurgery

Description: Undergo stereotactic radiosurgery

Arm Group Label: Arm 2 (stereotactic radiosurgery, surgery)

Intervention Type: Procedure

Intervention Name: Therapeutic Conventional Surgery

Description: Undergo surgery

Arm Group Label: Arm 2 (stereotactic radiosurgery, surgery)

Intervention Type: Other

Intervention Name: Laboratory Biomarker Analysis

Description: Correlative studies

Arm Group Label: Arm 2 (stereotactic radiosurgery, surgery)

Eligibility

Criteria:

Inclusion Criteria:

- Pathologically confirmed metastatic breast cancer

- Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis

- ≤ 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:

- peripheral lung

- osseous (bone)

- spine

- central lung

- abdominal-pelvic(lymph node/adrenal gland)

- liver

- mediastinal/cervical lymph node

- All known disease amenable to metastasis-directed therapy with either SBRT or resection

- NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered

- NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites

- NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy

- Maximum diameter of individual metastasis in any dimension ≤ 5 cm

- There are no restrictions on distance between the metastases

- Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis. First-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2 or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given. If given before study entry, it cannot have exceeded a duration of 12 months at the time of registration. (Note: Sequencing of ablative therapy (surgery or SBRT) relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician.)

- The primary tumor site must be controlled prior to registration

- For those who present with synchronous primary and oligometastatic disease:

Primary must be controlled prior to registration. The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference

- For those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference

- Appropriate stage for study entry based on the following diagnostic workup:

- History/physical examination within 60 days prior to registration

- Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration

- Zubrod performance status ≤ 2 within 60 days prior to registration

- Absolute neutrophil count (ANC) ≥ 500 cells/mm^3

- Platelets ≥ 50,000 cells/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)

- For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration

Exclusion Criteria:

- Pathologic evidence of local/regional breast tumor recurrence at the time of registration

- Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported

- Metastases with indistinct borders making targeting not feasible

- NOTE: A potential issue with bone metastases is that they often are not discrete. Since many patients on this protocol will have bone metastases, this will be an important issue. Theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU). Therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required

- Prior palliative radiation treatment for metastatic disease (including radiopharmaceuticals)

- 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)

- Brainstem previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)

- Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction)

- Primary tumor irradiated with SBRT

- Metastasis irradiated with SBRT

- Brain metastases

- Exudative, bloody, or cytological proven malignant effusions

- Severe, active co-morbidity defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

- Transmural myocardial infarction within the last 6 months

- 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 at the time of registration

- Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible

- 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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Steven Chmura Principal Investigator NRG Oncology
Location
Facility: Status:
University of Alabama at Birmingham Cancer Center | Birmingham, Alabama, 35233, United States Suspended
CTCA at Western Regional Medical Center | Goodyear, Arizona, 85338, United States Suspended
Arizona Center for Cancer Care-Peoria | Peoria, Arizona, 85381, United States Active, not recruiting
University of Arizona Cancer Center-Orange Grove Campus | Tucson, Arizona, 85704, United States Suspended
Banner University Medical Center - Tucson | Tucson, Arizona, 85719, United States Suspended
University of Arizona Cancer Center-North Campus | Tucson, Arizona, 85719, United States Suspended
Alta Bates Summit Medical Center-Herrick Campus | Berkeley, California, 94704, United States Suspended
UC San Diego Moores Cancer Center | La Jolla, California, 92093, United States Active, not recruiting
Los Angeles County-USC Medical Center | Los Angeles, California, 90033, United States Suspended
USC / Norris Comprehensive Cancer Center | Los Angeles, California, 90033, United States Suspended
Cedars Sinai Medical Center | Los Angeles, California, 90048, United States Active, not recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange, California, 92868, United States Suspended
The Permanente Medical Group-Roseville Radiation Oncology | Roseville, California, 95678, United States Suspended
Sutter Medical Center Sacramento | Sacramento, California, 95816, United States Suspended
University of California Davis Comprehensive Cancer Center | Sacramento, California, 95817, United States Active, not recruiting
Naval Medical Center -San Diego | San Diego, California, 92134, United States Active, not recruiting
Kaiser Permanente Cancer Treatment Center | South San Francisco, California, 94080, United States Suspended
Saint Joseph's Medical Center | Stockton, California, 95204, United States Suspended
Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee, California, 96161, United States Active, not recruiting
University of Colorado Hospital | Aurora, Colorado, 80045, United States Suspended
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado, 80907, United States Suspended
UCHealth Memorial Hospital Central | Colorado Springs, Colorado, 80909, United States Active, not recruiting
Poudre Valley Hospital | Fort Collins, Colorado, 80524, United States Suspended
McKee Medical Center | Loveland, Colorado, 80539, United States Suspended
Helen F Graham Cancer Center | Newark, Delaware, 19713, United States Suspended
University of Florida Health Science Center - Gainesville | Gainesville, Florida, 32610, United States Active, not recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood, Florida, 33021, United States Suspended
Mayo Clinic in Florida | Jacksonville, Florida, 32224-9980, United States Suspended
Miami Cancer Institute | Miami, Florida, 33176, United States Suspended
UF Cancer Center at Orlando Health | Orlando, Florida, 32806, United States Suspended
Memorial Hospital West | Pembroke Pines, Florida, 33028, United States Suspended
Emory University Hospital Midtown | Atlanta, Georgia, 30308, United States Suspended
Piedmont Hospital | Atlanta, Georgia, 30309, United States Active, not recruiting
Emory University Hospital/Winship Cancer Institute | Atlanta, Georgia, 30322, United States Suspended
Emory Saint Joseph's Hospital | Atlanta, Georgia, 30342, United States Suspended
John B Amos Cancer Center | Columbus, Georgia, 31904, United States Suspended
CTCA at Southeastern Regional Medical Center | Newnan, Georgia, 30265, United States Suspended
Lewis Hall Singletary Oncology Center | Thomasville, Georgia, 31792, United States Suspended
Queen's Medical Center | Honolulu, Hawaii, 96813, United States Suspended
The Cancer Center of Hawaii-Liliha | Honolulu, Hawaii, 96817, United States Suspended
Northwestern University | Chicago, Illinois, 60611, United States Suspended
Rush University Medical Center | Chicago, Illinois, 60612, United States Suspended
University of Illinois | Chicago, Illinois, 60612, United States Active, not recruiting
University of Chicago Comprehensive Cancer Center | Chicago, Illinois, 60637, United States Suspended
Decatur Memorial Hospital | Decatur, Illinois, 62526, United States Suspended
Northwestern Medicine Cancer Center Delnor | Geneva, Illinois, 60134, United States Suspended
Loyola University Medical Center | Maywood, Illinois, 60153, United States Suspended
Methodist Medical Center of Illinois | Peoria, Illinois, 61636, United States Suspended
Memorial Medical Center | Springfield, Illinois, 62781, United States Suspended
Southwest Illinois Health Services LLP | Swansea, Illinois, 62226, United States Suspended
Carle Cancer Center | Urbana, Illinois, 61801, United States Suspended
Northwestern Medicine Cancer Center Warrenville | Warrenville, Illinois, 60555, United States Suspended
Midwestern Regional Medical Center | Zion, Illinois, 60099, United States Suspended
Saint Vincent Anderson Regional Hospital/Cancer Center | Anderson, Indiana, 46016, United States Suspended
Parkview Hospital Randallia | Fort Wayne, Indiana, 46805, United States Active, not recruiting
Parkview Regional Medical Center | Fort Wayne, Indiana, 46845, United States Active, not recruiting
IU Health Ball Memorial Hospital | Muncie, Indiana, 47303, United States Active, not recruiting
Memorial Hospital of South Bend | South Bend, Indiana, 46601, United States Suspended
Ascension Via Christi Hospitals Wichita | Wichita, Kansas, 67214, United States Suspended
Owensboro Health Mitchell Memorial Cancer Center | Owensboro, Kentucky, 42303, United States Active, not recruiting
MaineHealth Coastal Cancer Treatment Center | Bath, Maine, 04530, United States Active, not recruiting
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford | Biddeford, Maine, 04005, United States Active, not recruiting
Maine Medical Center-Bramhall Campus | Portland, Maine, 04102, United States Active, not recruiting
MaineHealth Cancer Care Center of York County | Sanford, Maine, 04073, United States Active, not recruiting
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford | Sanford, Maine, 04073, United States Active, not recruiting
Maine Medical Center- Scarborough Campus | Scarborough, Maine, 04074, United States Active, not recruiting
University of Maryland/Greenebaum Cancer Center | Baltimore, Maryland, 21201, United States Suspended
Greater Baltimore Medical Center | Baltimore, Maryland, 21204, United States Suspended
UM Upper Chesapeake Medical Center | Bel Air, Maryland, 21014, United States Suspended
Central Maryland Radiation Oncology in Howard County | Columbia, Maryland, 21044, United States Suspended
Lahey Hospital and Medical Center | Burlington, Massachusetts, 01805, United States Suspended
Lowell General Hospital | Lowell, Massachusetts, 01854, United States Active, not recruiting
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109, United States Suspended
Henry Ford Cancer Institute-Downriver | Brownstown, Michigan, 48183, United States Suspended
21st Century Oncology MHP - Clarkston | Clarkston, Michigan, 48346, United States Suspended
Henry Ford Macomb Hospital-Clinton Township | Clinton Township, Michigan, 48038, United States Suspended
Henry Ford Hospital | Detroit, Michigan, 48202, United States Suspended
21st Century Oncology MHP - Farmington | Farmington Hills, Michigan, 48334, United States Suspended
West Michigan Cancer Center | Kalamazoo, Michigan, 49007, United States Suspended
Saint Joseph Mercy Oakland | Pontiac, Michigan, 48341, United States Suspended
William Beaumont Hospital-Royal Oak | Royal Oak, Michigan, 48073, United States Suspended
21st Century Oncology MHP - Troy | Troy, Michigan, 48098, United States Suspended
Henry Ford West Bloomfield Hospital | West Bloomfield, Michigan, 48322, United States Suspended
Mercy Hospital | Coon Rapids, Minnesota, 55433, United States Suspended
Saint Luke's Hospital of Duluth | Duluth, Minnesota, 55805, United States Active, not recruiting
Mayo Clinic | Rochester, Minnesota, 55905, United States Suspended
Regions Hospital | Saint Paul, Minnesota, 55101, United States Suspended
Saint Francis Medical Center | Cape Girardeau, Missouri, 63703, United States Suspended
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Suspended
Mercy Hospital South | Saint Louis, Missouri, 63128, United States Suspended
Missouri Baptist Medical Center | Saint Louis, Missouri, 63131, United States Suspended
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana, 59405, United States Suspended
Kalispell Regional Medical Center | Kalispell, Montana, 59901, United States Suspended
University of Nebraska Medical Center | Omaha, Nebraska, 68198, United States Active, not recruiting
Renown Regional Medical Center | Reno, Nevada, 89502, United States Suspended
Wentworth-Douglass Hospital | Dover, New Hampshire, 03820, United States Suspended
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States Active, not recruiting
Virtua Memorial | Mount Holly, New Jersey, 08060, United States Active, not recruiting
Community Medical Center | Toms River, New Jersey, 08755, United States Suspended
Virtua Voorhees | Voorhees, New Jersey, 08043, United States Active, not recruiting
Lovelace Medical Center-Saint Joseph Square | Albuquerque, New Mexico, 87102, United States Suspended
University of New Mexico Cancer Center | Albuquerque, New Mexico, 87102, United States Suspended
Lovelace Radiation Oncology | Albuquerque, New Mexico, 87109, United States Suspended
New Mexico Oncology Hematology Consultants | Albuquerque, New Mexico, 87109, United States Suspended
Christus Saint Vincent Regional Cancer Center | Santa Fe, New Mexico, 87505, United States Active, not recruiting
Montefiore Medical Center - Moses Campus | Bronx, New York, 10467, United States Active, not recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York, New York, 10032, United States Suspended
University of Rochester | Rochester, New York, 14642, United States Suspended
Dickstein Cancer Treatment Center | White Plains, New York, 10601, United States Active, not recruiting
Rex Hematology Oncology Associates-Cary | Cary, North Carolina, 27518, United States Suspended
UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, 27599, United States Active, not recruiting
Duke University Medical Center | Durham, North Carolina, 27710, United States Suspended
Rex Hematology Oncology Associates-Garner | Garner, North Carolina, 27529, United States Suspended
Rex Cancer Center | Raleigh, North Carolina, 27607, United States Suspended
Rex Hematology Oncology Associates-Blue Ridge | Raleigh, North Carolina, 27607, United States Suspended
Rex Cancer Center of Wakefield | Raleigh, North Carolina, 27614, United States Suspended
NHRMC Radiation Oncology - Supply | Supply, North Carolina, 28462, United States Suspended
New Hanover Regional Medical Center/Zimmer Cancer Center | Wilmington, North Carolina, 28401, United States Suspended
NHRMC Radiation Oncology - 16th Street | Wilmington, North Carolina, 28401, United States Suspended
Wake Forest University Health Sciences | Winston-Salem, North Carolina, 27157, United States Suspended
Sanford Bismarck Medical Center | Bismarck, North Dakota, 58501, United States Active, not recruiting
Cleveland Clinic Akron General | Akron, Ohio, 44307, United States Suspended
Case Western Reserve University | Cleveland, Ohio, 44106, United States Suspended
Ohio State University Comprehensive Cancer Center | Columbus, Ohio, 43210, United States Suspended
ProMedica Flower Hospital | Sylvania, Ohio, 43560, United States Suspended
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States Suspended
Legacy Mount Hood Medical Center | Gresham, Oregon, 97030, United States Suspended
Legacy Good Samaritan Hospital and Medical Center | Portland, Oregon, 97210, United States Suspended
Providence Portland Medical Center | Portland, Oregon, 97213, United States Suspended
Providence Saint Vincent Medical Center | Portland, Oregon, 97225, United States Suspended
UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg, Pennsylvania, 17109, United States Suspended
University of Pennsylvania/Abramson Cancer Center | Philadelphia, Pennsylvania, 19104, United States Active, not recruiting
Allegheny General Hospital | Pittsburgh, Pennsylvania, 15212, United States Suspended
UPMC-Shadyside Hospital | Pittsburgh, Pennsylvania, 15232, United States Suspended
Guthrie Medical Group PC-Robert Packer Hospital | Sayre, Pennsylvania, 18840, United States Suspended
Reading Hospital | West Reading, Pennsylvania, 19611, United States Active, not recruiting
Self Regional Healthcare | Greenwood, South Carolina, 29646, United States Suspended
Gibbs Cancer Center-Pelham | Greer, South Carolina, 29651, United States Suspended
Spartanburg Medical Center | Spartanburg, South Carolina, 29303, United States Suspended
Texas Oncology-Austin Midtown | Austin, Texas, 78705, United States Active, not recruiting
UT Southwestern/Simmons Cancer Center-Dallas | Dallas, Texas, 75390, United States Suspended
M D Anderson Cancer Center | Houston, Texas, 77030, United States Suspended
Ogden Regional Medical Center | Ogden, Utah, 84405, United States Suspended
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah, 84112, United States Active, not recruiting
Inova Fairfax Hospital | Falls Church, Virginia, 22042, United States Suspended
Bon Secours Saint Mary's Hospital | Richmond, Virginia, 23226, United States Suspended
Legacy Salmon Creek Hospital | Vancouver, Washington, 98686, United States Suspended
Edwards Comprehensive Cancer Center | Huntington, West Virginia, 25701, United States Suspended
West Virginia University Healthcare | Morgantown, West Virginia, 26506, United States Suspended
Saint Vincent Hospital Cancer Center Green Bay | Green Bay, Wisconsin, 54301, United States Suspended
Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay, Wisconsin, 54303, United States Suspended
Gundersen Lutheran Medical Center | La Crosse, Wisconsin, 54601, United States Suspended
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Suspended
Marshfield Clinic Stevens Point Center | Stevens Point, Wisconsin, 54482, United States Suspended
Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend, Wisconsin, 53095, United States Suspended
Diagnostic and Treatment Center | Weston, Wisconsin, 54476, United States Suspended
Tom Baker Cancer Centre | Calgary, Alberta, T2N 4N2, Canada Suspended
Cross Cancer Institute | Edmonton, Alberta, T6G 1Z2, Canada Suspended
London Regional Cancer Program | London, Ontario, N6A 4L6, Canada Suspended
Ottawa Hospital and Cancer Center-General Campus | Ottawa, Ontario, K1H 8L6, Canada Suspended
CHUM - Hopital Notre-Dame | Montreal, Quebec, H2L 4M1, Canada Recruiting Giuseppina L. Masucci 514-890-8000 23611 [email protected] Giuseppina L. Masucci Principal Investigator
McGill University Department of Oncology | Montreal, Quebec, H2W 1S6, Canada Recruiting Tarek Hijal 514-934-1934 42953 [email protected] Tarek Hijal Principal Investigator
CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal, Quebec, H2X 3E4, Canada Suspended
The Research Institute of the McGill University Health Centre (MUHC) | Montreal, Quebec, H3H 2R9, Canada Active, not recruiting
Jewish General Hospital | Montreal, Quebec, H3T 1E2, Canada Suspended
Yonsei University Health System-Severance Hospital | Seoul, 120-752, Korea, Republic of Suspended
King Faisal Specialist Hospital and Research Centre | Riyadh, 11211, Saudi Arabia Suspended
Location Countries

Canada

Korea, Republic of

Saudi Arabia

United States

Verification Date

April 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm 1 (standard of care)

Type: No Intervention

Description: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician.

Label: Arm 2 (stereotactic radiosurgery, surgery)

Type: Experimental

Description: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician. Patients also undergo stereotactic radiosurgery in 1, 3, or 5 fractions within 3 weeks and/or surgery at the discretion of the treating physician.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov