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Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704808
First received: June 23, 2008
Last updated: September 8, 2015
Last verified: September 2015
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
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: After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide ]
| Enrollment: | 180 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (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.
Other Names:
Radiation: Radiotherapy
Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.
Other Names:
Drug: Temozolomide
Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No Contacts or Locations Provided
More Information
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00704808 History of Changes |
| Other Study ID Numbers: |
P04739 |
| Study First Received: | June 23, 2008 |
| Results First Received: | March 17, 2010 |
| Last Updated: | September 8, 2015 |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on July 26, 2017