Cerebral Radiation NecrosisPhase 2NCT03067753

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

A Phase 2 study testing Monosialoganglioside Ganglioside, Methylprednisolone (Steroid Hormone) and Prednisolone in people with Cerebral Radiation Necrosis, run by Zhejiang Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cerebral Radiation Necrosis
What is being tested?: Monosialoganglioside Ganglioside, Methylprednisolone (Steroid Hormone) and Prednisolone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: Dec 2016to Sep 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

Xiaozhong Chen
Hangzhou, Zhejiang, 310022
Xiaozhong Chen, MD, +86-571-88128202, cxzfyun@sina.com
Recruiting

Other trials in China

About this study

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

Conditions: Cerebral Radiation Necrosis
Being tested: Monosialoganglioside Ganglioside, Methylprednisolone (Steroid Hormone), Prednisolone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03067753
Study group	Role	What they receive
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. Receives: Drug: Methylprednisolone (Steroid Hormone); Drug: Prednisolone
Monosialoganglioside ganglioside	Experimental	Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months. Receives: Drug: Monosialoganglioside Ganglioside

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate
Response Evaluation Criteria in Solid Tumors (RECIST) were used.
Measured: From the first day of treatment, to 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Sep 2019

First posted1 Mar 2017
Study startDec 2016
Primary completionSep 2019 (estimated)
Study completionSep 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cerebral Radiation NecrosisStudies of the same condition, open and under way.
More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03067753
Sponsor's protocol ID: ZJCH-2016-HN02
Status last verified: Jan 2017
First submitted: 10 Jan 2017
Last updated: 1 Mar 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Radiation Necrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis
ClinicalTrials.gov ID: NCT03067753
Acronym / sponsor ID: ZJCH-2016-HN02
Conditions: Cerebral Radiation Necrosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 28 participants (estimated)
Lead sponsor: Zhejiang Cancer HospitalUniversity, hospital or other
Study start: Dec 2016
Primary completion: Sep 2019 (estimated)
Study completion: Sep 2019 (estimated)
First posted: 1 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pulsed steroid	Active comparator	Drug: Methylprednisolone (Steroid Hormone), Drug: PrednisolonePulse 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.
Monosialoganglioside ganglioside	Experimental	Drug: Monosialoganglioside GangliosideMonosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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 ;

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Monosialoganglioside GangliosideMonosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.	Drug	Monosialoganglioside ganglioside
Methylprednisolone (Steroid Hormone)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	Pulsed steroid
Prednisolone	Drug	Pulsed steroid

Primary outcome

Objective response rate
Time frame: From the first day of treatment, to 3 months after treatment
Response Evaluation Criteria in Solid Tumors (RECIST) were used.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Individual participant dataSharing planned: No

Related trials for Cerebral Radiation Necrosis

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Development of MRF for Characterization of Brain Tumors After Radiotherapy
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REMASTer: REcurrent Brain Metastases After SRS Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaozhong Chen

Hangzhou, China

+86-571-88128202

cxzfyun@sina.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From the first day of treatment, to 3 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.