Clinical trial · Interventional
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma
NCT01621880CI-TRIAL-00036438BRAINcompletedPhase 2Results 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)
Bevacizumab may have a better effect on brain necrosis caused by radiotherapy.This randomized trial aims to investigate whether bevacizumab may alleviate radiation-induced brain necrosis in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Effect of Radiation Therapy | — | UNRESOLVED | — |
| Brain Necrosis | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| Corticosteroid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bevacizumab
- description
- Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- Corticosteroid
- description
- Patients in the corticosteroid group were treated with intravenous pulsed-steroid therapy: methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped.
- interventionNames
- Drug: Corticosteroid
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have received radiotherapy for histologically confirmed nasopharyngeal carcinoma. * Prior irradiation \>/= 6 months prior to study entry. * Radiographic evidence to support the diagnosis of radiation-induced brain necrosis without tumor recurrence. * Age\>/= 18 years. Because on dosing or adverse event data are currently not available on the use of bevacizumab in patients \<18years old. * No prior bevacizumab therapy. * No evidence of very high intracranial pressure that suggests brain hernia and needs surgery. * Fertile women who are willing to take contraception during the trial. * Routine laboratory studies with bilirubin \</=upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) \< ULN, creatinine \<ULN, red-cell count \>/= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; Hb \>/=9.0. PT, APTT, INR in a normal range. * If with history of seizures, patients should be on anticonvulsant therapy. However, preference will be enzyme-non-inducing anticonvulsants. * Ability to understand and willingness to sign a written informed consent document. * The patient has no active bleeding or pathological condition that carries a high risk of bleeding; there is no evidence of serious or non-healing wound, ulcer or bone fracture. Exclusion Criteria: * Patients with any of the following should be excluded: 1) evidence of metastatic disease; 2)evidence of tumor invasion to major vessels(e.g. the carotid); 3) history of bleeding related to tumor or radiotherapy during or after the completion of radiation. * Evidence of active central nervous system hemorrhage. * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to study enrollment. * inadequately controlled hypertension (systolic blood pressure (SBP) \> 140 mmHg and/or diastolic blood pressure (DBP) \> 90 mmHg despite antihypertensive medication) * Severe complications: 1) History of large vessel cerebrovascular accident (CVA) within 6 months; 2) Myocardial infarction or unstable angina within 6 months; 3) New York heart association grade II or greater congestive heart failure; 4) Serious and inadequately controlled cardiac arrhythmia; 5) Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 6) Clinically significant peripheral vascular disease; 7) severe infection. * Evidence of bleeding diathesis or coagulopathy. * Patients who have received steroid therapy for radiation-induced brain necrosis before the study. * History of anaphylactic response to bevacizumab.
References
Publications (2)
- DERIVEDLuo S, Lai S, Wu Y, Hong J, Lin D, Lin S, Huang X, Xu X, Weng X. Cost-effectiveness analysis of bevacizumab for cerebral radiation necrosis treatment based on real-world utility value in China. Strahlenther Onkol. 2024 Sep;200(9):805-814. doi: 10.1007/s00066-024-02242-6. Epub 2024 Jun 3. PMID 38829437
- DERIVEDXu Y, Rong X, Hu W, Huang X, Li Y, Zheng D, Cai Z, Zuo Z, Tang Y. Bevacizumab Monotherapy Reduces Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma Patients: A Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2018 Aug 1;101(5):1087-1095. doi: 10.1016/j.ijrobp.2018.04.068. Epub 2018 May 2. PMID 29885994