Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases

Study Purpose

This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- The primary lesion pre-operatively can have a maximum diameter of =< 4 cm for single fraction and =< 7 cm for multifraction therapy.

- Patients must be considered candidates for SRS within +/- 30 days of surgical resection as defined by either history and physical (H&P) or presentation at brain metastasis tumor board conference note.

- Patients must have a Karnofsky performance scores >= 70 or Eastern Cooperative Oncology Group (ECOG) >= 2 within 30 days of enrollment.

- Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form.

- No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review.

- Documented history of malignancy.

Exclusion Criteria:

- Patients who have received prior radiation therapy to the brain for any reason.

- The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.

- For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03741673
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Debra N Yeboa
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
Study Website:	View Trial Website

Additional Details

PRIMARY OBJECTIVE:

I. To investigate the 1 year leptomeningeal disease (LMD)-free rate among patients with surgically resectable metastatic brain lesions randomized to post-operative stereotactic radiosurgery (SRS) (standard care) versus pre-operative SRS followed by surgery (experimental arm).

SECONDARY OBJECTIVE:

I. To investigate the local control (LC), distant brain metastasis rate, overall survival (OS) of pre-operative (pre-op) versus (vs.#46; post-operative (post-op) SRS in patients with brain metastasis.

EXPLORATORY OBJECTIVES:

I. To assess the reliability of different imaging features by using a combination of patient data and phantom data to quantify the uncertainties associated with using magnetic resonance imaging (MRI) for radiomics studies.

II. To assess the correlation of imaging-pathology correlates using multiparametric imaging that characterize the tumor and peri-tumoral microenvironment including features such as tumor vascular characteristics, cellular density, oxygenation and presence of inflammation/immune reactivity.

III. To investigate the neuro-cognitive impact, patient reported outcomes and health-related quality of life of pre-operative (pre-op) vs.#46;post-operative (post-op) SRS in patients with brain metastasis.

OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (PRE-OPERATIVE SRS): Patients undergo SRS within 15 days of randomization followed by surgery within 15 days. Patients may undergo additional SRS if disease returns after treatment. GROUP II (POST-OPERATIVE SRS): Patients undergo surgery within 15 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment. After completion of study treatment, patients are followed up periodically.

Arms & Interventions

Arms

Experimental: Group I (pre-operative SRS)

Patients undergo SRS within 30 days of randomization followed by surgery within 30 days. Patients may undergo additional SRS if disease returns after treatment.

Active Comparator: Group II (post-operative SRS)

Patients undergo surgery within 30 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.

Interventions

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Questionnaire Administration

Ancillary studies

Radiation: - Stereotactic Radiosurgery

Undergo SRS

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Debra N. Yeboa

[email protected]

713-563-2300