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Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Radiotherapy, Nasopharyngeal Carcinoma, Cerebral Radiation Necrosis, MRI

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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

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