- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01621880
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma (BRAIN)
December 19, 2018 updated by: Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bevacizumab
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.
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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.
Other Names:
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Active Comparator: Corticosteroid
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Treatment Response
Time Frame: At 2 months.
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The primary outcome of the trial was the treatment response rate at two months.
The definitions of response and progressive disease were based on both the radiographic changes and clinical symptoms.
We defined response as both (1)a reduction in edema volume on FLAIR images by ≥25% and (2)no deteriorating symptoms.
Progressive disease was defined as either (1)larger than 10% increase in the volume of the lesions; (2)appearance of any new lesion/site; or (3)clear clinical worsening.
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At 2 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change in Radiological Measures of Lesion Volume
Time Frame: Change from baseline to evaluation at 2 months.
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T1 post-gadolinium imaging was used to measure the enhancement and T2-weighted FLAIR to measure the edema.
For lesion measurements, radiologists used manual and semiautomatic approaches to identify the outline of the lesion, and the total volume was estimated with Volume Viewer 2 software(GE Healthcare, AW Suite2.0 6.5.1.z).
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Change from baseline to evaluation at 2 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yamei Tang, Ph.D, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2012
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 14, 2012
First Submitted That Met QC Criteria
June 14, 2012
First Posted (Estimate)
June 18, 2012
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
December 19, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Necrosis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Neuroprotective Agents
- Protective Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Methylprednisolone
- Bevacizumab
Other Study ID Numbers
- 2012025
- SYSN001 (Other Identifier: Sun Yat-sen Memorial Hospital, Neurology department)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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