Trial Title:
Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy
NCT ID:
NCT05703269
Condition:
NSCLC
Renal Cell Carcinoma
Breast Carcinoma
Melanoma
Brain Metastases, Adult
Non-small Cell Lung Cancer
SCLC
Small-cell Lung Cancer
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Renal Cell
Small Cell Lung Carcinoma
Brain Neoplasms
Breast Neoplasms
Conditions: Keywords:
Gamma Knife
Linear Accelerator
Immune Checkpoint Inhibitor (ICI) therapy
Stereotactic Radiosurgery (SRS)
Fractionated Stereotactic Radiosurgery (FSRS)
Stereotactic Radiosurgery (SSRS)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Participants will be randomized 1:1 to either SSRS or FSRS, using minimization
randomization strategy considering 5 prognostic factors of interest: radiosurgery
platform (GK vs. LINAC), timing of immunotherapy relative to radiation (ICI within 30
days of Day 1 prior to SRS or not), surgical status (any resection cavity vs. intact
metastases only), predominant tumor type (Melanoma vs. all others), and prior courses of
SRS for brain metastases (yes vs. no). All baseline patient-reported outcomes and
neurocognitive assessments will be collected prior to randomization to minimize bias.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
single fraction stereotactic radiosurgery (SSRS)
Description:
SSRS is an advanced radiation technique that delivers high dose precision radiation in a
single dose to discrete intracranial lesions.
Arm group label:
SSRS = single fraction stereotactic radiosurgery
Intervention type:
Radiation
Intervention name:
fractionated stereotactic radiosurgery (FSRS)
Description:
FSRS is an advanced radiation technique that uses a lower dose precision radiation
delivered over 3 to 5 treatments given daily or every other day to intracranial lesions.
Arm group label:
FSRS = fractionated stereotactic radiosurgery
Summary:
This study is designed to see if we can lower the chance of side effects from radiation
in patients with breast, kidney, small cell lung cancer, non-small cell lung cancer or
melanoma that has spread to the brain and who are also being treated with immunotherapy,
specifically immune checkpoint inhibitor (ICI) therapy. This study will compare the usual
care treatment of single fraction stereotactic radiosurgery (SSRS) given on one day
versus fractionated stereotactic radiosurgery (FSRS), which is a lower dose of radiation
given over a few days to determine if FSRS is better or worse at reducing side effects
than usual care treatment.
Detailed description:
This study is an open-label, randomized, Phase III trial designed to ascertain whether
fractionated stereotactic radiosurgery (FSRS) results in lower incidence of Grade 2 or
higher adverse radiation effect (ARE) by 9 months compared to single fraction
stereotactic radiosurgery (SSRS) in patients with large brain metastases who have
received or will receive immune checkpoint inhibitor (ICI) targeted to the PD-1/PD-L1
axis within 30 days of stereotactic radiosurgery (SRS). Participants will be randomized
1:1 to either SSRS or FSRS, using a minimization randomization strategy considering 5
prognostic factors of interest: radiosurgery platform (gamma knife vs. LINAC), timing of
immunotherapy relative to radiation (ICI within 30 days prior to Day 1 of SRS or not),
surgical status (any resection cavity vs intact metastases only), predominant tumor type
(Melanoma vs. all others), and prior courses of SRS for brain metastases (yes vs. no).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4
cc volume.
- Patients at initial diagnosis of brain metastases and patients with known brain
metastasis treated with systemic therapy alone are eligible.
- Patients who have previously undergone SRS for brain metastases are eligible if
all MRIs and DICOM-RT files from prior SRS courses are available for upload to
TRIAD and there are no lesions requiring re-irradiation. Prior SRS data upload
is NOT required prior to enrollment and randomization. Both SSRS and FSRS are
acceptable.
- Lesion volume will be approximated by measuring the lesion's three
perpendicular diameters on contrast-enhanced, T1-weighted MRI and the product
of those diameters will be divided by 2 to estimate the lesion volume (e.g.,
xyz/2). Alternatively, direct volumetric measurements via slice-by-slice
contouring on a treatment planning software package can be used to calculate
the total tumor volume.
- Any extent of non-CNS disease is allowed. There is no requirement for non-CNS
disease to be controlled prior to study entry.
- For patients considered to be borderline or potentially eligible by size or
volume criteria, sites have the option to send in DICOM films for central
review screening.
- Age ≥ 18 years at the time of enrollment.
- Total number of brain metastases (including resection cavities) ≤ 15 on diagnostic
MRI; all lesions must be amenable to SSRS and FSRS as determined by the treating
radiation oncologist. Treatment must take place at a facility credentialed by the
Imaging and Radiation Oncology Core (IROC) for SRS and that offers both SSRS and
FSRS as treatment options.
- Total gross tumor volume must be ≤ 30 cc. Lesion volume will be approximated by
measuring each lesion's three perpendicular diameters on contrast-enhanced T1 MRI
and the product of those diameters will be divided by 2 (V = xyz/2). Direct
volumetric measurements by contouring all lesions on all visible slices on treatment
planning software is also acceptable. If there is a cavity, only gross residual
disease within or adjacent to the cavity is counted toward the 30 cc total volume.
- Ability to tolerate MRI brain with gadolinium-based contrast.
- Pathologically confirmed melanoma, renal cell carcinoma, non-small cell lung cancer,
small cell lung cancer, or breast cancer.
- Has received, is currently receiving, or is planned to receive immune checkpoint
inhibitor therapy (defined as agent targeted to PD-1/PD-L1 axis) within 30 days of
the planned first day of SSRS/FSRS. Dual ICI therapy with PD-1/PD-L1 and CTLA-4
targeted agents are allowed, but patients treated with a single agent CTLA-4
targeted agent only are ineligible.
o It is not mandatory to wait for the results of next generation sequencing (NGS) or
other molecular tumor testing to determine if the patient is planned to receive ICI
if the enrolling physician feels that identification of a mutation that would
preclude ICI therapy (such as an EGFR mutation in a patient with NSCLC) is unlikely
to be identified.
- Karnofsky Performance Status (KPS) ≥ 50. Refer to Appendix A.
- Negative serum or urine pregnancy test within 14 days of randomization for women of
child-bearing potential.
- Ability to understand and the willingness to sign written informed consent.
- Patients must be able to provide informed consent.
- Must be able to speak, read and understand English or Spanish
Exclusion Criteria:
- Prior fractionated, whole, or partial brain radiation therapy. Prior fractionated
SRS is acceptable.
- Prior courses of SRS for benign tumors such as meningiomas, pituitary adenomas,
schwannomas may be acceptable if the treatment is > 2cm away from the site of a
metastatic lesion that would be treated on this study. The study PI or a designated
co-PI must review this type of case to confirm eligibility prior to enrollment.
- Prior diagnosis ARE, including pseudoprogression or radiation
necrosis/radionecrosis, or previously treated lesions being actively evaluated for
possible ARE or local failure such as concerning imaging findings currently being
tracked with short interval MRI.
- Leptomeningeal carcinomatosis established by lumbar puncture cytology, or MRI
imaging. In the absence of a clinical indication, a lumbar puncture is not required
to confirm eligibility.
- A brain metastasis that is 5 mm or less from the optic chiasm or optic nerves
- Inability to tolerate brain MRI or receive gadolinium-based contrast
- Planned or prior therapy with bevacizumab (or bevacizumab biosimilar) within 30 days
of the planned first day of SRS as part of a systemic therapy regimen at study
enrollment.
- Serious intercurrent illness or medical condition judged by the local investigator
to compromise the patient's safety, preclude safe administration of the planned
protocol treatment, or would not permit the patient to be managed according to the
protocol guidelines.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Decatur Memorial Hospital
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A Faller
Email:
Principal Investigator
Facility:
Name:
Crossroads Cancer Center
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan Faller
Email:
Principal Investigator
Facility:
Name:
HSHS Saint Elizabeth's Hospital
Address:
City:
O'Fallon
Zip:
62269
Country:
United States
Status:
Recruiting
Contact:
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan Faller
Email:
Principal Investigator
Facility:
Name:
OSF Saint Francis Medical Center
Address:
City:
Peoria
Zip:
61637
Country:
United States
Status:
Recruiting
Contact:
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan Faller
Email:
Principal Investigator
Facility:
Name:
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Address:
City:
Ann Arbor
Zip:
48106
Country:
United States
Status:
Recruiting
Contact:
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Address:
City:
Brighton
Zip:
48114
Country:
United States
Status:
Recruiting
Contact:
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Genesys Hurley Cancer Institute
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health Saint Mary Mercy Livonia Hospital
Address:
City:
Livonia
Zip:
48154
Country:
United States
Status:
Recruiting
Contact:
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Address:
City:
Ypsilanti
Zip:
48197
Country:
United States
Status:
Recruiting
Contact:
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Samir Narayan
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital South
Address:
City:
Saint Louis
Zip:
63128
Country:
United States
Status:
Recruiting
Contact:
Phone:
314-525-6042
Email:
Danielle.Werle@mercy.net
Investigator:
Last name:
Jay Carlson
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital Springfield
Address:
City:
Springfield
Zip:
65804
Country:
United States
Status:
Recruiting
Contact:
Phone:
417-269-4520
Investigator:
Last name:
Jay W Carlson
Email:
Principal Investigator
Facility:
Name:
Overlook Medical Center
Address:
City:
Summit
Zip:
07901
Country:
United States
Status:
Recruiting
Contact:
Phone:
908-522-2043
Investigator:
Last name:
Joana S Emmolo
Email:
Principal Investigator
Facility:
Name:
Lovelace Medical Center-Saint Joseph Square
Address:
City:
Albuquerque
Zip:
87102
Country:
United States
Status:
Recruiting
Contact:
Phone:
505-272-0530
Email:
AYost@nmcca.org
Investigator:
Last name:
Heyoung L McBride
Email:
Principal Investigator
Facility:
Name:
Lovelace Radiation Oncology
Address:
City:
Albuquerque
Zip:
87109
Country:
United States
Status:
Recruiting
Contact:
Phone:
505-272-0530
Email:
AYost@nmcca.org
Investigator:
Last name:
Heyoung L McBride
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Einstein Campus
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Justin Tang
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Weiler Hospital
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Justin Tang
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center - Moses Campus
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Contact:
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Justin Tang
Email:
Principal Investigator
Facility:
Name:
Carolinas Medical Center/Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28203
Country:
United States
Status:
Recruiting
Contact:
Phone:
800-804-9376
Investigator:
Last name:
Roshan Prabhu
Email:
Principal Investigator
Facility:
Name:
Atrium Health Cabarrus/LCI-Concord
Address:
City:
Concord
Zip:
28025
Country:
United States
Status:
Recruiting
Contact:
Phone:
800-804-9376
Investigator:
Last name:
Roshan Prabhu
Email:
Principal Investigator
Facility:
Name:
Wake Forest University Health Sciences
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Phone:
336-713-6771
Investigator:
Last name:
Christina K Cramer
Email:
Principal Investigator
Facility:
Name:
Sanford Broadway Medical Center
Address:
City:
Fargo
Zip:
58122
Country:
United States
Status:
Recruiting
Contact:
Phone:
701-323-5760
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquish
Email:
Principal Investigator
Facility:
Name:
Sanford Roger Maris Cancer Center
Address:
City:
Fargo
Zip:
58122
Country:
United States
Status:
Recruiting
Contact:
Phone:
701-234-6161
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Mercy Health - Perrysburg Hospital
Address:
City:
Perrysburg
Zip:
43551
Country:
United States
Status:
Recruiting
Contact:
Phone:
614-488-2745
Email:
Jeffh@columbusccop.org
Investigator:
Last name:
William Wilson
Email:
Principal Investigator
Facility:
Name:
Gibbs Cancer Center-Pelham
Address:
City:
Greer
Zip:
29651
Country:
United States
Status:
Recruiting
Contact:
Phone:
864-560-6104
Email:
kmertz-rivera@gibbscc.org
Investigator:
Last name:
Jeremy M Kilburn
Email:
Principal Investigator
Facility:
Name:
Spartanburg Medical Center
Address:
City:
Spartanburg
Zip:
29303
Country:
United States
Status:
Recruiting
Contact:
Phone:
864-560-6104
Email:
kmertz-rivera@gibbscc.org
Investigator:
Last name:
Jeremy M Kilburn
Email:
Principal Investigator
Facility:
Name:
Sanford Cancer Center Oncology Clinic
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Status:
Recruiting
Contact:
Phone:
605-312-3320
Email:
OncologyClinicTrialsSF@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Sanford USD Medical Center - Sioux Falls
Address:
City:
Sioux Falls
Zip:
57117-5134
Country:
United States
Status:
Recruiting
Contact:
Phone:
605-312-3320
Email:
OncologyClinicalTrialsSF@SanfordHealth.org
Investigator:
Last name:
Daniel Alquist
Email:
Principal Investigator
Facility:
Name:
Aspirus Langlade Hospital
Address:
City:
Antigo
Zip:
54409
Country:
United States
Status:
Recruiting
Contact:
Phone:
715-623-9869
Email:
Juli.Alford@aspirus.org
Investigator:
Last name:
Andrew J Huang
Email:
Principal Investigator
Facility:
Name:
Aspirus Cancer Care - James Beck Cancer Center
Address:
City:
Rhinelander
Zip:
54501
Country:
United States
Status:
Recruiting
Contact:
Phone:
715-847-2353
Email:
Beth.Knetter@aspirus.org
Investigator:
Last name:
Andrew J Huang
Email:
Principal Investigator
Facility:
Name:
Aspirus Cancer Care - Stevens Point
Address:
City:
Stevens Point
Zip:
54481
Country:
United States
Status:
Recruiting
Contact:
Phone:
715-847-2353
Email:
Beth.Knetter@aspirus.org
Investigator:
Last name:
Andrew Huang
Email:
Principal Investigator
Facility:
Name:
Aspirus Regional Cancer Center
Address:
City:
Wausau
Zip:
54401
Country:
United States
Status:
Recruiting
Contact:
Phone:
877-405-6866
Investigator:
Last name:
Andrew J Huang
Email:
Principal Investigator
Facility:
Name:
Aspirus Cancer Care - Wisconsin Rapids
Address:
City:
Wisconsin Rapids
Zip:
54494
Country:
United States
Status:
Recruiting
Contact:
Phone:
715-422-7718
Investigator:
Last name:
Andrew J Huang
Email:
Principal Investigator
Start date:
July 11, 2023
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05703269
