NCT03067753

Brief Summary

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

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
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2016

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

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 1, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 10, 2017

Last Update Submit

February 24, 2017

Conditions

Cerebral Radiation Necrosis

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Response Evaluation Criteria in Solid Tumors (RECIST) were used.

    From the first day of treatment, to 3 months after treatment

Study Arms (2)

Pulsed steroid

ACTIVE COMPARATOR

Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.

Drug: Methylprednisolone (Steroid Hormone)Drug: Prednisolone

Monosialoganglioside ganglioside

EXPERIMENTAL

Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.

Drug: Monosialoganglioside Ganglioside

Interventions

Monosialoganglioside GangliosideDRUG

Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.

Monosialoganglioside ganglioside
Methylprednisolone (Steroid Hormone)DRUG

Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.

Pulsed steroid
PrednisoloneDRUG
Pulsed steroid

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergone only one course of definitive radiotherapy for histologically confirmed nasopharyngeal carcinoma years before;
  • At least two consecutive MRI study supporting the diagnosis of cerebral radiation necrosis(CRN) with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI;
  • Progressive neurologic symptoms or signs;
  • Mini-mental status examination(MMSE) score must be ≤27;
  • Karnofsky performance status≥70 ;
  • Supposed to live more than 6 months.

You may not qualify if:

  • After the second course of radiotherapy for recurrent nasopharyngeal carcinoma;
  • Local or regional relapse,or with distant metastasis;
  • Cerebrovascular disease;
  • Second primary malignancy;
  • Diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaozhong Chen

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

G(M1) GangliosideMethylprednisolonePrednisolone

Intervention Hierarchy (Ancestors)

GangliosidesAcidic GlycosphingolipidsGlycosphingolipidsGlycolipidsGlycoconjugatesCarbohydratesLipidsSphingolipidsMembrane LipidsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

March 1, 2017

Study Start

December 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

March 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)