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NCT01019434

Radiation Therapy and Temsirolimus or Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

Radiation Therapy and Concurrent Plus Adjuvant Temsirolimus (CCI-779) Versus Chemo-Irradiation With Temozolomide in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Gene Promoter - A Randomized Multicenter, Open-Label, Phase II Study.
European Organisation for Research and Treatment of Cancer - EORTC·Phase 2·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Brain and Central Nervous System Tumors
Drug/Device/Intervention
temozolomide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Location
Leuven,Nantes-Saint Herblain,Paris,Freiburg,Heidelberg,Bologna,Den Haag,Rotterdam,Badalona,Bellinzona,Zurich,Bebington,Edinburgh, Belgium,France,Germany,Italy,Netherlands,Spain,Switzerland,United Kingdom
Timeline & enrollment
Phase
Phase 2
Start date
Oct 01, 2009
End date
Mar 01, 2014
Enrollment
111 participants
Primary outcome

Overall survival at 1 year

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Temsirolimus may
 stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs
 used in chemotherapy, such as temozolomide, work in different ways to stop the growth of
 tumor cells, either by killing the cells or by stopping them from dividing. It is not yet
 known whether radiation therapy is more effective when given together with temsirolimus or
 temozolomide in treating patients with glioblastoma.
 
 PURPOSE: This randomized phase II trial is studying giving radiation therapy together with
 temsirolimus to see how well it works compared with giving radiation therapy together with
 temozolomide in treating patients with newly diagnosed glioblastoma.

ICD-10 classifications
Malignant neoplasm: Overlapping lesion of brain and other parts of central nervous systemMalignant neoplasm: Central nervous system, unspecifiedBenign neoplasm of brain and other parts of central nervous systemMalignant neoplasm of brainSecondary malignant neoplasm of other and unspecified parts of nervous system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT01019434
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT01019434 through Pure Global AI's free database. This Phase 2 trial is sponsored by European Organisation for Research and Treatment of Cancer - EORTC and is currently Completed. The study focuses on Brain and Central Nervous System Tumors. Target enrollment is 111 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.