Clinical trial · Interventional
Radiosurgery and Avastin for Recurrent Malignant Gliomas
NCT01017250CI-TRIAL-00013908completedN/AResults postedClinicalTrials.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)
The purpose of this study is to assess the central nervous system (CNS) toxicity in patients with recurrent malignant gliomas treated with concurrent Avastin and stereotactic radiosurgery (SRS).
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 |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Stereotactic Radiosurgery (SRS) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiosurgery
- description
- Avastin and Radiosurgery
- interventionNames
- Radiation: Stereotactic Radiosurgery (SRS)
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Central Nervous System (CNS) Toxicity
- timeFrame
- 2 months after Stereotactic Radiosurgery
- description
- Number of participants who experience Grade 3 or higher adverse events in the "Nervous System Disorder" domain of Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
Secondary outcomes (16)
- measure
- Progression-free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * History of malignant glioma (WHO Grade III or IV) of the brain treated with some combination of surgery, biochemotherapy and conventionally fractionated external beam radiotherapy * Radiotherapy completed at least 6 months prior to recurrence * Age 18 years and older * New or enlarging contrast-enhancing and/or 18FDG-avid nodule, at least 1 cm diameter * Estimated life expectancy of 3 months or longer Exclusion Criteria: * Avastin therapy within 21 days of start of participation * Contraindication to Avastin therapy or brain MRI * Presence of bleeding diathesis or coagulopathy * History of prior arterial thrombotic event, myocardial infarction, angina, CVA, TIA, CABG angioplasty or stenting within 6 months. * Inadequately controlled hypertension (defined as systolic blood pressure * New York Heart Association (NYHA) Grade II or greater congestive heart failure * Clinically significant vascular disease * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to onset of treatment * Prior history of hypertensive crisis or hypertensive encephalopathy * History of abdominal fistula or GI perforation within 6 months prior to onset of treatment * Serious non-healing wound, active ulcer or untreated bone fracture * Proteinuria demonstrated by Urine Protein Creatinine ratio \> 1.0 * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.