NCT04553510

Brief Summary

Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

5 years

First QC Date

May 5, 2017

Last Update Submit

September 14, 2020

Conditions

Nasopharyngeal CarcinomaAdverse Effect of Radiation TherapyBrain Injuries

Outcome Measures

Primary Outcomes (1)

  • Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients

    Change in MRI of radiation-induced brain necrosis in patients

    Change form baseline to evaluation at 12 weeks

Secondary Outcomes (2)

  • Change of neurologic function of patients after treatment

    Change from baseline to evaluation at 12 weks.

  • Change of quality of life of patients after treatment

    Change from baseline to evaluation at 12 weeks.

Study Arms (2)

Bevacizumab and steroid

EXPERIMENTAL

Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.

Drug: Bevacizumab and steroid

Bevacizumab and placebo

ACTIVE COMPARATOR

Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.

Drug: Bevacizumab and placebo

Interventions

Bevacizumab and steroidDRUG

Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.

Bevacizumab and steroid
Bevacizumab and placeboDRUG

Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.

Bevacizumab and placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have received radiotherapy for histologically confirmed nasopharyngeal carcinoma.
  • Prior irradiation \>/= 6 months prior to study entry.
  • Radiographic evidence to support the diagnosis of radiation-induced brain necrosis without tumor recurrence.
  • Age\>/= 18 years. Because on dosing or adverse event data are currently not available on the use of bevacizumab in patients \<18years old.
  • No prior bevacizumab therapy.
  • No evidence of very high intracranial pressure that suggests brain hernia and needs 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. PT, APTT, INR in a normal range.
  • If with history of seizures, patients should be on anticonvulsant therapy. However, preference will be enzyme-non-inducing anticonvulsants.
  • Ability to understand and willingness to sign a written informed consent document.
  • The patient has no active bleeding or pathological condition that carries a high risk of bleeding; there is no evidence of serious or non-healing wound, ulcer or bone fracture.

You may not qualify if:

  • evidence of metastatic disease;
  • evidence of tumor invasion to major vessels(e.g. the carotid);
  • history of bleeding related to tumor or radiotherapy during or after the completion of radiation.
  • Evidence of active central nervous system hemorrhage.
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to study enrollment.
  • inadequately controlled hypertension (systolic blood pressure (SBP) \> 140 mmHg and/or diastolic blood pressure (DBP) \> 90 mmHg despite antihypertensive medication)
  • Severe complications: 1) History of large vessel cerebrovascular accident (CVA) within 6 months; 2) Myocardial infarction or unstable angina within 6 months; 3) New York heart association grade II or greater congestive heart failure; 4) Serious and inadequately controlled cardiac arrhythmia; 5) Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 6) Clinically significant peripheral vascular disease; 7) severe infection.
  • Evidence of bleeding diathesis or coagulopathy.
  • Patients who have received steroid therapy for radiation-induced brain necrosis before the study.
  • History of anaphylactic response to bevacizumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal CarcinomaRadiation InjuriesBrain Injuries

Interventions

BevacizumabSteroids

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesWounds and InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Tang Yamei, Ph.D

    sun yat-sen memorial hospital,sun yat-sen universicy

    STUDY DIRECTOR

Central Study Contacts

Tang Yamei, Ph.D

CONTACT

86-13556001992yameitang@hotmail.com

Yi Li, Ph.D

CONTACT

86-150187615121024254327@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 5, 2017

First Posted

September 17, 2020

Study Start

January 1, 2016

Primary Completion

December 31, 2020

Study Completion

June 30, 2021

Last Updated

September 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)