Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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To evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. detailed description:

Detailed Description
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This was a single-arm, open-label study. We aimed to evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. Magnetic resonance imaging (MRI) was performed pre- and post-treatment to define the radiographic response.The primary outcome was a 2-month response rate as determined by MRI and clinical symptoms. All of the patients were followed up with for 6 months.

Official Title
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A Single-arm Phase II Study of Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Endostar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cytologically or histologically proven Nasopharyngeal Carcinoma(WHO 2003 I-III) . Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region; age ≥18 years; radiation therapy history for histologically confirmed NPC administered≥6 months prior to study entry; radiographic evidence to support the diagnosis of RN with out tumor recurrence or metastases; patients had never received Antiangiogenic agents for RN treatment prior to the screening; patients had never received corticosteroids for RN treatment prior to the screening; no evidence of very high intracranial pressure suggestive of a brain hernia requiring surgery routine laboratory studies including urinalysis, complete blood count, liver function, renal function, and coagulation test within a normal range; to understand and be willing to sign a written informed consent. Exclusion Criteria: Other types of Nasopharyngeal Carcinoma; Recurrent nasopharyngeal carcinoma, resection of encephalopathy, metastasis, hepatitis, other malignant tumors, neurovascular diseases, or other diseases of the nervous system; Inadequately controlled diabetes (FBG > 10mmol/L) and hypertension(systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Other severe concurrent disorders that occurred before enrollment (severe or unstable angor, NYHA class 3 or 4 congestive heart failure, Myocardial infarction occurred within 6 months before enrollment；Aortic dissection aortic aneurysm.) active central nervous system hemorrhage; pregnant or lactating women, women who have not undergone a pregnancy test (within 14 days prior to initial administration), and pregnant women; Patients with a history of severe mental illness or communication disorders.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostar combined with Methylprednisolone<br>Endostar combined with Methylprednisolone lasts for 10 weeks | Drug: Endostar<br>* Endostar: 210 mg (14 PCS) continuous infusion for 168h, Q3W, 4 cycles. Methylprednisolone: 80mg intravenously, once daily, for 3-5 days, gradually reduced to 10mg/ day oral maintenance dose.<br>* Other names: Re-human endostain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | 2-month response rate as determined by MRI and clinical symptoms | All of the patients were followed up with for 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endostar, Radiation-induced Brain Necrosis, Nasopharyngeal Carcinoma