NCT01670890

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

August 19, 2012

Last Update Submit

August 21, 2012

Conditions

Malignant Gliomas

Keywords

temozolomide(TMZ)cisplatin(CDDP)recurrent malignant gliomas

Outcome Measures

Primary Outcomes (1)

  • over all survival

    1 year

Secondary Outcomes (1)

  • progression free survival

    6 months

Study Arms (2)

TMZ group

ACTIVE COMPARATOR

patients were treated with TMZ alone

Drug: TMZ

TMZ plus CDDP group

EXPERIMENTAL

patients were treated with TMZ plus CDDP

Drug: TMZ plus CDDP

Interventions

TMZDRUG

patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles

Also known as: temozolomide
TMZ group
TMZ plus CDDPDRUG

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

Also known as: temozolomide and cisplatin
TMZ plus CDDP group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Tiantan Hospital Affiliated to Capital Medial University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Tianjin medical university general university

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

TemozolomideCisplatin

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • wang renzhi, MD

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

wang renzhi, MD

CONTACT

86-010-69156071wangrz@126.com

Wang yu, MD

CONTACT

86-010-69156071kingrichwy@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2012

First Posted

August 22, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

CN(3)