Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

NCT ID: NCT03067753

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-09-30

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

Conditions

Cerebral Radiation Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulsed steroid

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.

Group Type: ACTIVE_COMPARATOR

Methylprednisolone (Steroid Hormone)

Intervention Type: 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.

Prednisolone

Intervention Type: DRUG

Monosialoganglioside ganglioside

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

Group Type: EXPERIMENTAL

Monosialoganglioside Ganglioside

Intervention Type: DRUG

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

Interventions

Monosialoganglioside Ganglioside

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Prednisolone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiaozhong Chen

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xiaozhong Chen, MD

Role: primary

cxzfyun@sina.com

+86-571-88128202

Other Identifiers

ZJCH-2016-HN02

Identifier Type: -

Identifier Source: org_study_id