Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Study Overview
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Brief Summary
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Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Detailed Description
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A prospective phase II trial was conducted to test the efficacy of monosialoganglioside ganglioside for the treatment of cerebral radiation necrosis

Conditions
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Cerebral Radiation Necrosis

Intervention / Treatment
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* Drug: Monosialoganglioside Ganglioside
* Drug: Methylprednisolone (Steroid Hormone)
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergone only one course of definitive radiotherapy for histologically confirmed nasopharyngeal carcinoma years before; At least two consecutive MRI study supporting the diagnosis of cerebral radiation necrosis(CRN) with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI; Progressive neurologic symptoms or signs; Mini-mental status examination(MMSE) score must be ≤27; Karnofsky performance status≥70 ; Supposed to live more than 6 months. Exclusion Criteria: After the second course of radiotherapy for recurrent nasopharyngeal carcinoma; Local or regional relapse,or with distant metastasis; Cerebrovascular disease; Second primary malignancy; Diabetes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed steroid<br>Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone. | Drug: Methylprednisolone (Steroid Hormone)<br>* Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.<br>Drug: Prednisolone<br> <br> |
| Experimental: Monosialoganglioside ganglioside<br>Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months. | Drug: Monosialoganglioside Ganglioside<br>* Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Response Evaluation Criteria in Solid Tumors (RECIST) were used. | From the first day of treatment, to 3 months after treatment |