Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas
NCT ID: NCT01670890
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2012-08-31
Brief Summary
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The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of TMZ and CDDP in patients with recurrent malignant gliomas
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TMZ group
patients were treated with TMZ alone
TMZ
patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles
TMZ plus CDDP group
patients were treated with TMZ plus CDDP
TMZ plus CDDP
patients were treated with TMZ plus CDDP,CDDP was administered iv from day 1 to 3 with the total dose of 100mg and TMZ was administered orally 50mg/m2/day,day 1 to 28,for 6 cycles
Interventions
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TMZ
patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles
TMZ plus CDDP
patients were treated with TMZ plus CDDP,CDDP was administered iv from day 1 to 3 with the total dose of 100mg and TMZ was administered orally 50mg/m2/day,day 1 to 28,for 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age\>=18 and \<=70years old
* Histological diagnosis of malignant gliomas(WHO III or IV)
* The status of methylation of promotor of MGMT should be detected.
* The time to be enrolled should be more than 90 days after the irradiation.
* The patients with recurrent gliomas were treated with non-dose-dense TMZ therapy before enrollment.
* Performance status(Karnofsky index)\>=60
* Life expectancy more than 3 months
Exclusion Criteria
* Abnormal function of liver or renal(value more than 1.5 fold normal upper limit )
* Blood routing: Hb \< 100g/l， WBC \< 4.0×109/l; PLT \< 100×109/l
* Pregnant or lactating women
* Allergic to administered drugs
* Radiation treatment in the previous 90 days or stereotactic radiation surgery within 60 days before enrollment
* The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.
* Life expectancy less than 3 months
* Participation in other clinical trials in the 90previous days before enrollment
18 Years
70 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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wang renzhi, MD
Role: STUDY_CHAIR
Peking Union Medical College Hospital
Locations
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Beijing Tiantan Hospital Affiliated to Capital Medial University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Tianjin medical university general university
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jiang tao, MD
Role: primary
wang ren zhi, MD
Role: primary
Yang xue jun, MD
Role: primary
Other Identifiers
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pumch-neurosurgery-01
Identifier Type: -
Identifier Source: org_study_id