ClinicalTrials.gg
Status unknownNCT03067753Updated Mar 1, 2017

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

A Phase 2 interventional study of Monosialoganglioside Ganglioside and Methylprednisolone (Steroid Hormone) in Cerebral Radiation Necrosis, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Read the detailed description

A prospective phase II trial was conducted to test the efficacy of monosialoganglioside ganglioside for the treatment of cerebral radiation necrosis

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Conditions studied

  • Cerebral Radiation Necrosis
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In context

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 281 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Active comparator
    Pulsed steroid

    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

  • Experimental
    Monosialoganglioside ganglioside

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

    Drug: Monosialoganglioside Ganglioside

Interventions

  • DrugMonosialoganglioside Ganglioside

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

  • 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.

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What researchers measure

Primary outcomes

  1. Objective response rate

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

    Time frame: From the first day of treatment, to 3 months after treatment

07

Study locations

1 of 1 sites recruiting
  • Xiaozhong Chen
    Hangzhou, Zhejiang 310022, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03067753
Responsible party
Sponsor
First posted
Mar 1, 2017
Start date
Dec 2016
Primary completion
Sep 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Mar 1, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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