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Nasopharyngeal Carcinoma

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Prednisolone

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Edaravone

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Edaravone was used at a dose of 30mg,intravenously, twice per day, for 14 days. All patients also received common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.

All patients in this group received common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.

Be used at a dose of 30mg, intravenously, twice per day, for 14 days.

common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.

Common fundamental management

Yamei Tang, M.D.,PhD.

It is hypothesized that excessive generation of free radicals involves in the pathogenesis of radiation-induced brain necrosis. This study therefore evaluated the effect of free radical scavenger, edaravone, on radiation-induced temporal lobe necrosis (TLN) in patients with nasopharyngeal carcinoma (NPC) after radiotherapy.

Radiation-induced temporal lobe necrosis (TLN) is the most serious sequelae of radiotherapy and impairs the patients' quality of life profoundly. Steroid is one of the conventional treatment methods for TLN. However, its response rate was still not so satisfactory (about 30%-35%).The mechanism of TLN is under exploring and not completely understood. It has been proposed recently that chronic oxidative stress and inflammation involve in the pathogenesis of radiation-induced late normal tissue injury.

Edaravone(3-methyl-1-phenyl-2-pyrazolin-5-one), which is proved to be an excellent free radical scavenger, has been applied to a wide range of oxidative stress-related diseases.Thus, it may exert a therapeutic effect on radiation-induced temporal lobe necrosis. To support this hypothesis, the investigators carried out a randomized study of combining edaravone with common fundamental management versus common fundamental therapy in patients with TLN, and analyzed the Late Effects of Normal Tissues -Subjective, Objective, Management, Analytic (LENT/SOMA) scale before and after treatment.

Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis

Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy

The radiographic response was assessed by difference between MRI pretreatment and post-treatment, which included T1-weighted gadolinium contrast-enhanced and T2-weighted image. The maximum area measurement of the radiation necrosis lesions were recorded (the product of the longest trans diameter and its longest perpendicular). And the change of the maximum area of the necrosis lesion on MRI three months after treatment was used as the secondary end point.

Clinical symptoms and signs were evaluated by Late Effects of Normal Tissues -Subjective, Objective, Management, Analytic (LENT/SOMA) scale(16) before drug administration and three months after treatment. Subjective domain contains five items: headache, somnolence, intellectual deficit, functional competence, and memory. Objective domain contains four items: neurologic deficit, cognitive functions, mood \& personality changes, and seizures. And Analytic domain includes neuropsychologic and radiologic assessments. Each domain scores from 0 to 4. The summary of each domain represents the final score of LENT/SOMA scale. The primary end point was the change in LENT/SOMA scale scores at three months after treatment from base line.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Professor

Bevacizumab

Prednisone

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

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.

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.

bevacizumab

Corticosteroid

Yamei Tang, Ph.D

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.

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.

Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma

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.

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).

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.

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.

Patients in the corticosteroid group were treated with 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.

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.

Patients in the corticosteroid group were treated with 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.

Corticosteroid: Patients in the corticosteroid group were treated with 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.

Total

Age, Continuous

Sex: Female, Male

China

Region of Enrollment

Conventional radiotherapy

IMRT(intensity modulated radiation therapy)

Dose of nasopharyngeal radiation

Dose of neck radiation

Yamei Tang

Number of Participants With a Treatment Response

Percentage Change in FLAIR

Percentage Change in enhancement

Patients in the corticosteroid group were treated 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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis	NCT01865201	Nasopharyngeal ... Brain Necrosis	Edaravone Common fundamen...	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis	NCT01865201	Nasopharyngeal ... Brain Necrosis	Edaravone Common fundamen...	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma	NCT01621880	Nasopharyngeal ... Adverse Effect ... Brain Necrosis	bevacizumab Corticosteroid	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis	NCT01865201	Nasopharyngeal ... Brain Necrosis	Edaravone Common fundamen...	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma	NCT01621880	Nasopharyngeal ... Adverse Effect ... Brain Necrosis	bevacizumab Corticosteroid	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma	NCT01621880	Nasopharyngeal ... Adverse Effect ... Brain Necrosis	bevacizumab Corticosteroid	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for brain necrosis