Phase 2
N=112
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma · Adverse Effect of Radiation Therapy · Brain Necrosis
Bottom Line
View on ClinicalTrials.gov: NCT01621880 ↗Enrolled (actual)
112
Serious AEs
1.8%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With a Treatment Response — 38; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Drug); Corticosteroid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Treatment Response |
38; 17 | — |
| SECONDARY Percentage Change in Radiological Measures of Lesion Volume |
-51.8; -19.3; -25.5; -5.0 | — |
Summary
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.
Eligibility Criteria
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 /= 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.
Data sourced from ClinicalTrials.gov (NCT01621880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.