Overview

Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
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, edaravone, on radiation-induced temporal lobe necrosis (TLN) in patients with nasopharyngeal carcinoma (NPC) after radiotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Treatments:
Antipyrine
Edaravone
Mannitol
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Phenylmethylpyrazolone
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- 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 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 Criteria:

- 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.