Status:
COMPLETED
Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Nasopharyngeal Carcinoma
Brain Necrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
It is hypothesized that excessive generation of free radicals involves in the pathogenesis of radiation-induced brain necrosis. This study therefore evaluated the effect of free radical scavenger, eda...
Detailed Description
Radiation-induced temporal lobe necrosis (TLN) is the most serious sequelae of radiotherapy and impairs the patients' quality of life profoundly. Steroid is one of the conventional treatment methods f...
Eligibility Criteria
Inclusion
- ①Patients must have received radiation therapy for histologically confirmed nasopharyngeal carcinoma.
- Prior irradiation \>/= 6 months prior to study entry.
- Radiographic evidence to support the diagnosis of radiation-induced temporal lobe necrosis without tumor recurrence(15).
- Age\>/= 18 years.
- No evidence of very high intracranial pressure that suggests brain hernia and need surgery.
- Fertile women who are willing to take contraception during the trial.
- Routine laboratory studies with bilirubin \</=2 \* upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) \< 2 \* ULN, creatinine \<1.5 \* ULN, red-cell count \>/= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; Hb \>/=9.0. prothrombin time(PT), activated partial thromboplastin time(APTT),international normalized ratio(INR) in a normal range.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion
- ①Tumor recurrence or metastases.
- Diseases of central nervous system, such as cerebral vascular events, inflammatory, degenerative disease, and significant cardiovascular diseases.
- Severe systemic diseases.
- History of anaphylactic response to edaravone.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01865201
Start Date
March 1 2009
End Date
September 1 2012
Last Update
December 12 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120