Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis

NCT01865201 | Completed Phase 2 DMC

• 1 other identifier: 2009001
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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, edaravone, on radiation-induced temporal lobe necrosis (TLN) in patients with nasopharyngeal carcinoma (NPC) after radiotherapy.

Conditions

Nasopharyngeal Carcinoma; Brain Necrosis

Keywords

Radiotherapy; Radiation-induced brain necrosis; Edaravone; Effectiveness; Safety

Outcome Measures

Primary Outcomes (1)

• The change of the maximum area of the necrosis lesion on MRI three months after treatment

  The radiographic response was assessed by difference between MRI pretreatment and post-treatment, which included T1-weighted gadolinium contrast-enhanced and T2-weighted image. The maximum area measurement of the radiation necrosis lesions were recorded (the product of the longest trans diameter and its longest perpendicular). And the change of the maximum area of the necrosis lesion on MRI three months after treatment was used as the secondary end point.

  At three months after treatment

Secondary Outcomes (1)

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

  Three months after treatment

Study Arms (2)

Edaravone group

EXPERIMENTAL

Edaravone was used at a dose of 30mg,intravenously, twice per day, for 14 days. All patients also received common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.

Drug: Edaravone

Control group

EXPERIMENTAL

All patients in this group received common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.

Other: Common fundamental management

Interventions

Edaravone DRUG

Be used at a dose of 30mg, intravenously, twice per day, for 14 days.

Also known as: 3-Methyl-1-phenyl-2-pyrazolin-5-one

Edaravone group

Common fundamental management OTHER

common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.

Also known as: Methlprednisolone, Mannitol

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• Tang Y, Rong X, Hu W, Li G, Yang X, Yang J, Xu P, Luo J. Effect of edaravone on radiation-induced brain necrosis in patients with nasopharyngeal carcinoma after radiotherapy: a randomized controlled trial. J Neurooncol. 2014 Nov;120(2):441-7. doi: 10.1007/s11060-014-1573-4. Epub 2014 Aug 21.

  PMID: 25142813 DERIVED

Related Links

• The homepage of Sun Yat-sen Memorial Hospital, Sun Yat-sen University

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Edaravone; Mannitol

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Yamei Tang, M.D.,PhD.

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2013
• First Posted: May 30, 2013
• Study Start: March 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: September 1, 2012
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

CN (1)