Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Phase 2

• Conditions: Cerebral Radiation Necrosis
• Interventions: Drug: Methylprednisolone (Steroid Hormone); Drug: Monosialoganglioside Ganglioside; Drug: Prednisolone

• Registration Number: NCT03067753
• Lead Sponsor: Zhejiang Cancer Hospital

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

Study Timeline

• Study Start: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-02-24
• Last Update Submitted: 2017-02-24
• Study First Posted: 2017-03-01
• Last Update Posted: 2017-03-01
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pulsed steroid	Methylprednisolone (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.
Monosialoganglioside ganglioside	Monosialoganglioside Ganglioside	Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.
Pulsed steroid	Prednisolone	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.

Primary Outcome Measures

Name	Time	Method
Objective response rate	From the first day of treatment, to 3 months after treatment	Response Evaluation Criteria in Solid Tumors (RECIST) were used.

Trial Locations

Locations (1)

Xiaozhong Chen; 🇨🇳 Hangzhou, Zhejiang, China