PMS: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704808

Purpose

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

Condition	Intervention
Glioblastoma	Procedure: Primary surgical treatment Radiation: Radiotherapy Drug: Temozolomide

MedlinePlus related topics: Cancer Radiation Therapy Surgery

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Median progression free survival after primary surgical treatment, concomitant and adjuvant chemotherapy with temozolomide, for patients with newly diagnosed glioblastoma multiforme [ Time Frame: 3 months, 6 months, 9 months, and 12 months after start of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of toxicity (per National Cancer Institute Common Toxicity Criteria) [ Time Frame: 3 months, 6 months, 9 months, and 12 months after start of treatment. ] [ Designated as safety issue: Yes ]
Progression free survival [ Time Frame: 3 months, 6 months, 9 months, and 12 months after start of treatment. ] [ Designated as safety issue: No ]
Determination of overall survival [ Time Frame: One year from end of treatment. ] [ Designated as safety issue: No ]
Karnofsky performance status [ Time Frame: One year from end of treatment. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	180
Study Start Date:	April 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients Patients with newly diagnosed and operated glioblastoma multiforme.	Procedure: Primary surgical treatment Primary surgery for tumor resection. Radiation: Radiotherapy Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics. Drug: Temozolomide Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.

Groups/Cohorts

Assigned Interventions

Patients

Patients with newly diagnosed and operated glioblastoma multiforme.

Procedure: Primary surgical treatment

Primary surgery for tumor resection.

Radiation: Radiotherapy

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

Drug: Temozolomide

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with newly diagnosed glioblastoma multiforme.

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04739
Study First Received:	June 23, 2008
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00704808 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Adjuvants, Immunologic
Neuroepithelioma

Antineoplastic Agents, Alkylating
Glioblastoma Multiforme
Glioma
Alkylating Agents
Temozolomide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009