Clinical trial · Interventional
Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases
A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases
NCT03741673CI-TRIAL-00121134active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Metastatic Malignant Neoplasm in the Brain | Brain Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (pre-operative SRS)
- description
- Patients undergo SRS within 30 days of randomization followed by surgery within 30 days. Patients may undergo additional SRS if disease returns after treatment.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Radiation: Stereotactic Radiosurgery
- type
- ACTIVE_COMPARATOR
- label
- Group II (post-operative SRS)
- description
- 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.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Radiation: Stereotactic Radiosurgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDYeboa DN, Li J, Lin R, Prabhu SS, Beckham TH, Woodhouse K, Swanson TA, Weinberg JS, Wang X, Chi X, Ejezie CL, Suki D, Wang C, Ene C, McCutcheon IE, McGovern S, McAleer MF, Tom M, Ghia A, Perni S, Jiang W, De B, Chung C, Kim BYS, O'Brien BJ, Huse JT, Wefel JS, Court L, Tawbi H, Janku F, Guha-Thakurta N, Debnam JM, Johnson J, Taslicay CA, Alvarez-Breckenridge C, Raza SM, Heimberger AB, DeMonte F, North R, Briere TM, de Groot JF, Sawaya R, Grosshans D, Lang FF, Rao G, Ferguson SD. Therapy, Safety, and Logistics of Preoperative vs Postoperative Stereotactic Radiation Therapy: A Preliminary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2025 Aug 1;11(8):890-899. doi: 10.1001/jamaoncol.2025.1770. PMID 40531511