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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

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