Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Zhejiang Cancer Hospital28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Radiation Necrosis

Interventions

Monosialoganglioside GangliosideDRUG

Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.

Methylprednisolone (Steroid Hormone)DRUG

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.

PrednisoloneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xiaozhong Chen

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Objective response rate

Response Evaluation Criteria in Solid Tumors (RECIST) were used.

Time frame: From the first day of treatment, to 3 months after treatment

Data from ClinicalTrials.gov

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