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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 September 2021 |
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Main ID: |
NCT02934256 |
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Date of registration:
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13/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Icotinib |
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Scientific title:
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Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02934256 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Fu Zhao |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Neurosurgical Institute |
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Name:
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Pinan Liu |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Tiantan Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients must be at the age of 16-50
2. Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma
and other central nervous system tumors
3. Patients must not be treated with other drugs or radiation therapy recently
4. Patients should live in Beijing or nearby and can be treated in hospital
5. Patients must be healthy and not be seriously allergic with biological agents
6. Patients must join the clinical trial voluntarily, with good compliance, cooperate
with the researchers well, sign a written informed consent.
Exclusion Criteria:
1. Treated with other drugs, surgery or radiation therapy recently
2. Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery
in short time
3. Being pregnant or try to get pregnant, lactating women
4. With acute or chronic infectious diseases
5. With heart diseases, cardiac dysfunction or abnormal ECG
6. With uncontrolled neural or mental diseases, poor compliance
7. Not available for enhanced MRI
8. Take part in any other clinical trial
9. With other conditions that are considered not suitable for this clinical trial.
Age minimum:
16 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neurofibromatosis Type 2
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Vestibular Schwannoma
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Intervention(s)
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Drug: Icotinib
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Primary Outcome(s)
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Change from Baseline in volume of tumour after every course of the treatment
[Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12]
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Secondary Outcome(s)
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Change from Baseline in hearing ability after every course of the treatment
[Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12]
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Secondary ID(s)
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Tian-drug-neuro002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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