Comparing pre-operative and post-operative stereotactic radiosurgery for brain metastases
A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases
This study is testing whether giving targeted radiation therapy before or after surgery helps people with brain metastases live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03741673 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the effectiveness of stereotactic radiosurgery (SRS) administered before surgery versus after surgery in patients with brain metastases. The primary objective is to evaluate the one-year leptomeningeal disease-free rate between the two approaches. Secondary objectives include assessing local control, distant brain metastasis rates, and overall survival. Additionally, the study explores the neuro-cognitive impact and quality of life associated with each treatment timing. Patients will be randomized into two groups to receive SRS either pre-operatively or post-operatively.
Who should consider this trial
Good fit: Ideal candidates are patients with surgically resectable brain metastases and a Karnofsky performance score of 70 or higher.
Not a fit: Patients with prior radiation therapy to the brain or those with small-cell lung cancer, lymphoma, leukemia, or multiple myeloma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients with brain metastases.
How similar studies have performed: Previous studies have shown promising results with stereotactic radiosurgery, but this specific comparison of pre-operative versus post-operative SRS is novel.
Eligibility criteria
Show full 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)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Debra N Yeboa — M.D. Anderson Cancer Center
- Study coordinator: Debra Yeboa
- Email: dnyeboa@mdanderson.org
- Phone: 713-563-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.