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Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Nasopharyngeal Carcinoma, Brain Necrosis

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Trial Information

Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy


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 for TLN. However, its response rate was still not so satisfactory (about
30%-35%).The mechanism of TLN is under exploring and not completely understood. It has been
proposed recently that chronic oxidative stress and inflammation involve in the pathogenesis
of radiation-induced late normal tissue injury.

Edaravone(3-methyl-1-phenyl-2-pyrazolin-5-one), which is proved to be an excellent free
radical scavenger, has been applied to a wide range of oxidative stress-related
diseases.Thus, it may exert a therapeutic effect on radiation-induced temporal lobe
necrosis. To support this hypothesis, the investigators carried out a randomized study of
combining edaravone with common fundamental management versus common fundamental therapy in
patients with TLN, and analyzed the Late Effects of Normal Tissues -Subjective, Objective,
Management, Analytic (LENT/SOMA) scale before and after treatment.


Inclusion Criteria:



- ‚φPatients 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:

- ‚φTumor 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The change in LENT/SOMA scale scores at three months after treatment from base line.

Outcome Description:

Clinical symptoms and signs were evaluated by Late Effects of Normal Tissues -Subjective, Objective, Management, Analytic (LENT/SOMA) scale(16) before drug administration and three months after treatment. Subjective domain contains five items: headache, somnolence, intellectual deficit, functional competence, and memory. Objective domain contains four items: neurologic deficit, cognitive functions, mood & personality changes, and seizures. And Analytic domain includes neuropsychologic and radiologic assessments. Each domain scores from 0 to 4. The summary of each domain represents the final score of LENT/SOMA scale. The primary end point was the change in LENT/SOMA scale scores at three months after treatment from base line.

Outcome Time Frame:

At three months after treatment

Safety Issue:

No

Principal Investigator

Yamei Tang, M.D.,PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

2009001

NCT ID:

NCT01865201

Start Date:

March 2009

Completion Date:

September 2012

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Brain Necrosis
  • Radiotherapy
  • Radiation-induced brain necrosis
  • Edaravone
  • Effectiveness
  • Safety
  • Carcinoma
  • Necrosis
  • Nasopharyngeal Neoplasms

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