Cerebral Radiation Necrosis
Conditions
Brief summary
Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis
Detailed description
A prospective phase II trial was conducted to test the efficacy of monosialoganglioside ganglioside for the treatment of cerebral radiation necrosis
Interventions
DRUGMonosialoganglioside Ganglioside
Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.
DRUGMethylprednisolone (Steroid Hormone)
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.
DRUGPrednisolone
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | From the first day of treatment, to 3 months after treatment | Response Evaluation Criteria in Solid Tumors (RECIST) were used. |
Countries
China
Outcome results
None listed