Glioblastoma
Conditions
Brief summary
The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.
Detailed description
Participant sampling method: consecutive patient sampling.
Interventions
DRUGTemozolomide
Temozolomide will be administered orally at 75 mg/m\^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.
RADIATIONRadiotherapy
Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed Glioblastoma multiforme
Exclusion criteria
* History of hypersensitivity to temozolomide or its components, or to dacarbazine. * Women who are pregnant or breast-feeding. * Patients with severe myelosuppression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Number of Adverse Events in the Indicated Categories | Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase |
| Number of Participants Who Discontinued Due to Toxicity | Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Planned Temozolomide+Radiotherapy Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Hepatopathy probably not Temodal-related | 1 |
| Overall Study | Intensified treatment scheme: 3 on 1 off | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | No further documentation | 1 |
| Overall Study | Suspect lymph nodes neck thorax abdomen | 1 |
| Overall Study | Toxicity | 9 |
| Overall Study | Tumor Progression | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Planned Temozolomide+Radiotherapy |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 12.06 |
| Region of Enrollment Austria | 50 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 44 | 1 / 6 |
| serious Total, serious adverse events | 8 / 44 | 1 / 6 |
Outcome results
Primary
Number of Participants Who Discontinued Due to Toxicity
Time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Temozolomide+Radiotherapy | Number of Participants Who Discontinued Due to Toxicity | 8 Participants |
| Temozolomide Alone | Number of Participants Who Discontinued Due to Toxicity | 1 Participants |
Primary
Safety: Number of Adverse Events in the Indicated Categories
Time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Temozolomide+Radiotherapy | Safety: Number of Adverse Events in the Indicated Categories | Unlikely Related to Temozolomide | 35 Adverse Events |
| Temozolomide+Radiotherapy | Safety: Number of Adverse Events in the Indicated Categories | Possibly Related to Temozolomide | 14 Adverse Events |
| Temozolomide+Radiotherapy | Safety: Number of Adverse Events in the Indicated Categories | Probably Related to Temozolomide | 22 Adverse Events |
| Temozolomide Alone | Safety: Number of Adverse Events in the Indicated Categories | Unlikely Related to Temozolomide | 1 Adverse Events |
| Temozolomide Alone | Safety: Number of Adverse Events in the Indicated Categories | Possibly Related to Temozolomide | 0 Adverse Events |
| Temozolomide Alone | Safety: Number of Adverse Events in the Indicated Categories | Probably Related to Temozolomide | 1 Adverse Events |