Brief Title
Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study
Official Title
Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis
Brief Summary
Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy
for cancers, and may have a devastating effect on the patient's quality of life (QOL).
However,CRN was once regarded as a progressive and irreversible disease, no standard therapy
has been suggested for CRN. In our clinical practice, we have used
monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully
reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.
Study Type
Observational [Patient Registry]
Primary Outcome
The necrotic volume showed on MRI
Secondary Outcome
relief of the symptoms related to CRN
Condition
Radiotherapy
Intervention
GM1
Study Arms / Comparison Groups
group one will receive non-GM1 conservative therapy
Description: Group one will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or "wait and see" policy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
January 2012
Completion Date
December 2014
Primary Completion Date
December 2014
Eligibility Criteria
Inclusion Criteria:
The necrotic mass shown on MRI must be measured in two dimensions. No local or regional
recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were
supposed to live more than 6 months.
Exclusion Criteria:
- CRN combined with local or regional relapse, or with distant metastasis. ② CRN
combined with other cerebrovascular disease. ③CRN combined with the second primary
malignancy. ④ CRN without neurologic symptoms or signs. ⑤ CRN combined with diabetes.
⑥CRN patients that were supposed to live less than 6 months.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
ChaoSu Hu, MD, PhD, 86-21-64175590, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01884987
Organization ID
CRN2013
Responsible Party
Principal Investigator
Study Sponsor
Fudan University
Study Sponsor
ChaoSu Hu, MD, PhD, Principal Investigator, Fudan University
Verification Date
January 2014