Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01884987
Recruitment Status : Unknown
Verified January 2014 by Fan Ming, Fudan University.
Recruitment status was:  Recruiting
First Posted : June 24, 2013
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):
Fan Ming, Fudan University

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.

Condition or disease Intervention/treatment
Radiotherapy Nasopharyngeal Carcinoma Cerebral Radiation Necrosis MRI Drug: GM1

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
group one will receive non-GM1 conservative therapy
Group one will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or "wait and see" policy
Drug: GM1
This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days.
Other Name: monosialotetrahexosylganglioside

Primary Outcome Measures :
  1. The necrotic volume showed on MRI [ Time Frame: 6-8 months ]

Secondary Outcome Measures :
  1. relief of the symptoms related to CRN [ Time Frame: 6-8 months ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients must have undergone definitive RT for histologically confirmed NPC years before. They were required to have at least two consecutive magnetic resonance imaging (MRI) study supporting the diagnosis of CRN with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI. The necrotic mass shown on MRI must be measured in two dimensions in order to define the response to treatment. Other radiologic studies were also required to support the non-existence of local or regional recurrence, distant metastasis. Patients must have undergone mental status examinations and had progressive neurologic symptoms or signs. In addition, they were required to have a Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01884987

Contact: ChaoSu Hu, MD, PhD 86-21-64175590 ext 1408
Contact: XiaoShen Wang, MD, PhD 86-21-64175590 ext 6702

Shanghai Cancer Center, Fudan University Recruiting
Shanghai, China, 200032
Contact: ChaoSu Hu, MD, PhD    86-21-64175590   
Sponsors and Collaborators
Fudan University
Principal Investigator: ChaoSu Hu, MD, PhD Fudan University

Responsible Party: Fan Ming, Professor, Fudan University Identifier: NCT01884987     History of Changes
Other Study ID Numbers: CRN2013
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pathologic Processes
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases