Trial Information
Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis
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.
Type of Study:
Observational [Patient Registry]
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The necrotic volume showed on MRI
Outcome Time Frame:
6-8 months
Safety Issue:
Yes
Principal Investigator
ChaoSu Hu, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Shanghai Cancer Center, Fudan University
Authority:
China: Science and Technology Commission of Shanghai Municipality
Study ID:
CRN2013
NCT ID:
NCT01884987
Start Date:
January 2012
Completion Date:
December 2014
Related Keywords:
- Radiotherapy
- Nasopharyngeal Carcinoma
- Cerebral Radiation Necrosis
- MRI
- Carcinoma
- Necrosis
- Nasopharyngeal Neoplasms