Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Cerebral Radiation Necrosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03067753
• Other study ID #: ZJCH-2016-HN02
• Status: Recruiting
• Phase: Phase 2
• First received: January 10, 2017
• Last updated: February 24, 2017
• Start date: December 2016
• Est. completion date: September 2019

Study information

• Verified date: January 2017
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Radiation Necrosis
• Necrosis

Intervention

Drug:
• Monosialoganglioside Ganglioside
Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.
• 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.
• Prednisolone

Locations

Country	Name	City	State
China	Xiaozhong Chen	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Response Evaluation Criteria in Solid Tumors (RECIST) were used.	From the first day of treatment, to 3 months after treatment