Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Fan Ming, Fudan University
ClinicalTrials.gov Identifier:
NCT01884987
First received: June 19, 2013
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Radiotherapy
Nasopharyngeal Carcinoma
Cerebral Radiation Necrosis
MRI
Drug: GM1
Phase 2

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • The necrotic volume showed on MRI [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • relief of the symptoms related to CRN [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884987

Contacts
Contact: ChaoSu Hu, MD, PhD 86-21-64175590 ext 1408 hucsu62@126.com
Contact: XiaoShen Wang, MD, PhD 86-21-64175590 ext 6702 ruijin702@163.com

Locations
China
Shanghai Cancer Center, Fudan University Recruiting
Shanghai, China, 200032
Contact: ChaoSu Hu, MD, PhD    86-21-64175590    hucsu62@126.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: ChaoSu Hu, MD, PhD Shanghai Cancer Center, Fudan University
  More Information

No publications provided

Responsible Party: Fan Ming, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT01884987     History of Changes
Other Study ID Numbers: CRN2013
Study First Received: June 19, 2013
Last Updated: January 6, 2014
Health Authority: China: Science and Technology Commission of Shanghai Municipality

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

ClinicalTrials.gov processed this record on September 30, 2014