N/A
Completed N=180
Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
Source: ClinicalTrials.gov NCT00704808 ↗Enrolled (actual)
180
Serious AEs
29.5%
Results posted
Apr 2010
Primary outcomePrimary: Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme — 9.57 Months
Summary
The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme |
9.57 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor =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.
Data sourced from ClinicalTrials.gov (NCT00704808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.