Clinical trial · Interventional
Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
NCT00107367CI-TRIAL-00013410unknownPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| intraoperative radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Local control rate as measured by MRI with contrast at 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan * Resectable disease * Histological evidence of metastatic carcinoma by intraoperative pathology * No primary lymphoma, germ cell carcinoma, or small cell lung cancer PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No uncontrolled hypertension * No unstable angina pectoris * No uncontrolled dysrhythmias Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious infection * No other medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis Endocrine therapy * Not specified Radiotherapy * No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery * No concurrent external beam radiotherapy to the brain * Not planning adjuvant whole brain radiotherapy after study therapy Surgery * Not specified Other * No other prior conventional or investigational local or systemic agents for brain metastasis
References
Publications (1)
- DERIVEDWeil RJ, Mavinkurve GG, Chao ST, Vogelbaum MA, Suh JH, Kolar M, Toms SA. Intraoperative radiotherapy to treat newly diagnosed solitary brain metastasis: initial experience and long-term outcomes. J Neurosurg. 2015 Apr;122(4):825-32. doi: 10.3171/2014.11.JNS1449. Epub 2015 Jan 23. PMID 25614945