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Radiation Therapy and Temsirolimus or Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma - Trial NCT01019434

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.

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NCT01019434
Phase 2
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT01019434
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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.

Study Focus

temozolomide

Interventional

drug

Sponsor & Location

European Organisation for Research and Treatment of Cancer - EORTC

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 2

Oct 01, 2009

Mar 01, 2014

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 system
Malignant neoplasm: Central nervous system, unspecified
Benign neoplasm of brain and other parts of central nervous system
Malignant neoplasm of brain
Secondary malignant neoplasm of other and unspecified parts of nervous system

Data Source

ClinicalTrials.gov

NCT01019434

Non-Device Trial