Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01884987
• Other study ID #: CRN2013
• Status: Recruiting
• Phase: Phase 2
• First received: June 19, 2013
• Last updated: January 6, 2014
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Fudan University
• Contact: ChaoSu Hu, MD, PhD
• Phone: 86-21-64175590
• Email: hucsu62[@]126.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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. ? CRN combined with other cerebrovascular disease. ?CRN combined with the second primary malignancy. ? CRN without neurologic symptoms or signs. ? CRN combined with diabetes. ?CRN patients that were supposed to live less than 6 months.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Radiation Necrosis
• MRI
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Necrosis
• Radiotherapy

Intervention

Drug:
• GM1
This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days.

Locations

Country	Name	City	State
China	Shanghai Cancer Center, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The necrotic volume showed on MRI		6-8 months	Yes
Secondary	relief of the symptoms related to CRN		6-8 months	Yes