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Efficacy and Safety of Salvage Treatment With Dose-dense TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas: a Multicentre,Prospective Clinical Study


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Malignant Gliomas

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Trial Information

Efficacy and Safety of Salvage Treatment With Dose-dense TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas: a Multicentre,Prospective Clinical Study


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

over all survival

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

wang renzhi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Peking Union Medical College Hospital

Authority:

China: Ministry of Health

Study ID:

pumch-neurosurgery-01

NCT ID:

NCT01670890

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Malignant Gliomas
  • temozolomide(TMZ)
  • cisplatin(CDDP)
  • recurrent malignant gliomas
  • Glioma

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