Clinical trial NCT03741673: Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases
Official title: A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Malignant Neoplasm
Metastatic Malignant Neoplasm in the Brain
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-11-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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) 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 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.

Eligibility 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)

Primary outcomes:
measure: Leptomeningeal disease (LMD)-free rate
timeFrame: At 1 year
Secondary outcomes:
measure: Local control rate
timeFrame: At 1 year
measure: Distant brain control
timeFrame: At 1 year
measure: Overall survival (OS)
timeFrame: At 1 year
Other outcomes:
measure: Delta radiomics
timeFrame: Up to 4 years
measure: Circulating tumor cell analysis
timeFrame: Up to 4 years
measure: Cerebral spinal fluid analysis
timeFrame: Up to 4 years
measure: Neurocognitive function measured by HVLT-R questionnaire
timeFrame: Up to 1 year from start of treatment
measure: Symptom burden questionnaire
timeFrame: Up to 1 year from start of treatment
measure: Health outcomes questionnaire
timeFrame: Up to 1 year from start of treatment
measure: Neurocognitive function measured by COWA questionnaire
timeFrame: Up to 1 year from start of treatment
measure: Neurocognitive function measured by TMT questionnaire
timeFrame: Up to 1 year from start of treatment
measure: Neurocognitive function measured by CTB COMP questionnaire
timeFrame: Up to 1 year from start of treatment
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Debra N Yeboa
role: PRINCIPAL_INVESTIGATOR
References: