Trial record 8 of 1611 for:
Open Studies | "Radiotherapy"
Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study
This study is currently recruiting participants.
Verified September 2013 by Fudan University
Information provided by (Responsible Party):
Fan Ming, Fudan University
First received: June 19, 2013
Last updated: September 27, 2013
Last verified: September 2013
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.
Cerebral Radiation Necrosis
||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:
||Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
group one will receive a " wait and see" policy
Group one will receive no drug ,just wait and see
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
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01884987
|Shanghai Cancer Center, Fudan University
|Shanghai, China, 200032 |
|Contact: ChaoSu Hu, MD, PhD 86-21-64175590 firstname.lastname@example.org |
||ChaoSu Hu, MD, PhD
||Shanghai Cancer Center, Fudan University
No publications provided
||Fan Ming, Professor, Fudan University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 19, 2013
||September 27, 2013
||China: Science and Technology Commission of Shanghai Municipality
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
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