Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas

This study is currently recruiting participants.
Verified August 2012 by Peking Union Medical College Hospital
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Tianjin Medical University General Hospital
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01670890
First received: August 19, 2012
Last updated: August 21, 2012
Last verified: August 2012

August 19, 2012
August 21, 2012
August 2012
August 2014   (final data collection date for primary outcome measure)
over all survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01670890 on ClinicalTrials.gov Archive Site
progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas
Efficacy and Safety of Salvage Treatment With Dose-dense TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas: a Multicentre,Prospective Clinical Study

Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ. Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment procedure has not been established yet.

The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of TMZ and CDDP in patients with recurrent malignant gliomas

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Gliomas
  • Drug: TMZ
    patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles
    Other Name: temozolomide
  • Drug: 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 Name: temozolomide and cisplatin
  • Active Comparator: TMZ group
    patients were treated with TMZ alone
    Intervention: Drug: TMZ
  • Experimental: TMZ plus CDDP group
    patients were treated with TMZ plus CDDP
    Intervention: Drug: TMZ plus CDDP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent
  • 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:

  • Ages:< 18 years or > 70 years
  • 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
Both
18 Years to 70 Years
No
Contact: wang renzhi, MD 86-010-69156071 wangrz@126.com
Contact: Wang yu, MD 86-010-69156071 kingrichwy@126.com
China
 
NCT01670890
pumch-neurosurgery-01
Yes
Peking Union Medical College Hospital
Peking Union Medical College Hospital
  • Beijing Tiantan Hospital
  • Tianjin Medical University General Hospital
Study Chair: wang renzhi, MD Peking Union Medical College Hospital
Peking Union Medical College Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP