Glioblastoma
Conditions
Brief summary
The purpose of this surveillance is to collect more safety and efficacy data in non-study patients during concomitant and adjuvant temozolomide therapy.
Interventions
PROCEDUREPrimary surgical treatment
Primary surgery for tumor resection.
RADIATIONRadiotherapy
Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.
DRUGTemozolomide
Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme | After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Temozolomide Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics \[SPC\]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC) | 180 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 7 |
| Overall Study | Discontinued prior to starting treatment | 14 |
| Overall Study | Early therapy discontinuation | 16 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Patient's decision | 11 |
| Overall Study | Treatment change | 1 |
| Overall Study | Tumor progression | 80 |
Baseline characteristics
| Characteristic | Temozolomide |
|---|---|
| Age, Continuous | 57.65 years STANDARD_DEVIATION 11.52 |
| Region of Enrollment Germany | 180 participants |
| Sex/Gender, Customized Female | 65 participants |
| Sex/Gender, Customized Male | 101 participants |
| Sex/Gender, Customized Unavailable | 14 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 166 |
| serious Total, serious adverse events | 49 / 166 |
Outcome results
Primary
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
Population: Intent-to-Treat population
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Temozolomide | Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme | 9.57 Months | Standard Error 1.18 |