Brief Title
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma
Official Title
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma
Brief 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.
Detailed Description
Radiation-induced brain necrosis is a severe complication of radiotherapy in patients with
Nasopharyngeal carcinoma. Current neuroprotective therapies show limited benefit in
ameliorating this complication of radiotherapy. This study is a randomized, single blind
clinical study. The primary aim of this study is to determine whether bevacizumab can
alleviate radiation-induced brain necrosis in patients with nasopharyngeal carcinoma, and to
compare the treating effect between bevacizumab and steroid.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With a Treatment Response
Secondary Outcome
Percentage Change in Radiological Measures of Lesion Volume
Condition
Nasopharyngeal Carcinoma
Intervention
bevacizumab
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
112
Start Date
June 2012
Completion Date
December 2015
Primary Completion Date
August 2015
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 <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 /= 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Yamei Tang, Ph.D, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01621880
Organization ID
2012025
Secondary IDs
SYSN001
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Sponsor
Yamei Tang, Ph.D, Principal Investigator, Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Verification Date
December 2018