Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

NCT00376103

Glioblastoma Multiforme

TERMINATED PHASE1/PHASE2

Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00128700

Brain and Central Nervous System Tumors

COMPLETED PHASE1/PHASE2

Preoperative Chemoradiation for Glioblastoma

NCT02092038

Glioblastoma

COMPLETED PHASE1

Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)

NCT03480867

Glioblastoma Multiforme, Adult

WITHDRAWN PHASE1

Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

NCT00548938

Glioblastoma Multiforme High-Grade Glioma

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

Patients with newly diagnosed and operated glioblastoma multiforme.

Primary surgical treatment

Intervention Type PROCEDURE

Primary surgery for tumor resection.

Radiotherapy

Intervention Type RADIATION

Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.

Temozolomide

Intervention Type DRUG

Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Primary surgical treatment

Primary surgery for tumor resection.

Intervention Type PROCEDURE

Radiotherapy

Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.

Intervention Type RADIATION

Temozolomide

Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Resection Operation Surgery Irradiation Radiation therapy Temodal Temodar SCH 052365

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor \<=1.5 cm by magnetic resonance imaging (MRI).
* Age \>=18 years.
* Hemoglobin \>=10 g/dL.
* White blood cell count \>=1.5x10\^9/L.
* Platelet count \>=100x10\^9/L.
* Blood urea \<=1.5 x upper limit of normal values (ULN).
* Creatinine \<=1.5 x ULN.
* Bilirubin \<=1.5 x ULN.
* Aspartate aminotransferase \<=3 x ULN.
* Alanine aminotransferase \<=3 x ULN.
* Alkaline phosphatase \<=2 x ULN.

Exclusion Criteria

* Tumor-specific pretreatment.
* Contraindication against radiotherapy and/or chemotherapy.
* Malignomas other than basaliomas.
* Existing or planned pregnancy or lactation or inadequate contraception.
* Psychiatric disease.
* Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No