Back to resultsMonosialoganglioside Ganglioside in Cerebral Radiation Necrosis
Primary Purpose
Cerebral Radiation Necrosis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Monosialoganglioside Ganglioside
Methylprednisolone (Steroid Hormone)
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Radiation Necrosis
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.
Sites / Locations
- Xiaozhong ChenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pulsed steroid
Monosialoganglioside ganglioside
Arm Description
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 was given at 100 mg/time, once a day for 2 months.
Outcomes
Primary Outcome Measures
Objective response rate
Response Evaluation Criteria in Solid Tumors (RECIST) were used.
Secondary Outcome Measures
Full Information
NCT ID
NCT03067753
First Posted
January 10, 2017
Last Updated
February 24, 2017
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03067753
Brief Title
Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Radiation Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulsed steroid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Monosialoganglioside ganglioside
Arm Type
Experimental
Arm Description
Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.
Intervention Type
Drug
Intervention Name(s)
Monosialoganglioside Ganglioside
Intervention Description
Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone (Steroid Hormone)
Intervention Description
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
Intervention Name(s)
Prednisolone
Primary Outcome Measure Information:
Title
Objective response rate
Description
Response Evaluation Criteria in Solid Tumors (RECIST) were used.
Time Frame
From the first day of treatment, to 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Xiaozhong Chen
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD
Phone
+86-571-88128202
Email
cxzfyun@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis
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