Clinical trial · Interventional
Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors
A Multi-Center, Open-Label Clinical Study to Evaluate the Safety and Performance of the Proxima GliaSite RTS, a Radiation Delivery System, in Patients With Recurrent Malignant Brain Tumors Undergoing Surgical Resection
- 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| intraoperative radiation therapy | Radiation | — | UNRESOLVED |
| iodine I 125 | Radiation | — | UNRESOLVED |
| surgical procedure | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Unifocal disease Progressive or recurrent disease following radiation therapy and/or chemotherapy Must be eligible for surgical resection of the tumor mass No unresectable leptomeningeal spread or ventricular invasion outside the radiation treatment volume No exophytic ventricular tumors Must have a maximal cross-sectional diameter enhancing tumor greater than 2.0 cm but not greater than 5.0 cm by preoperative MRI Ratio of major axes of the tumor should not exceed 1.5 No marked edema by preoperative MRI or CT that cannot be corrected by tumor resection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension, angina pectoris, or uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No serious concurrent infection or other medical illness No prior or concurrent malignancy within 5 years except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: At least 4 weeks since prior use of medical device No concurrent investigational agents
References
Publications (0)
Data not yet available