Trial Outcomes & Findings for Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform (NCT NCT01120639)
NCT ID: NCT01120639
Last Updated: 2021-08-06
Results Overview
The maximum-tolerated dose (MTD) of study treatment (temozolomid plus hypofractionated radiotherapy administered as 5 fractions) is defined as either: * The highest radiation dose per protocol, or * The radiation dose at which dose-limiting toxicities (DLTs) occurred in ≥ 2 of 3 participants at a dose level, and/or ≥ 2 of 6 participants, at a dose level. Dose-limiting toxicity (DLT) was defined as a treatment-related (with possible, probable or definite attribution) Grade 3 to 5 CNS toxicity \[Common Terminology Criteria for Adverse Events (CTCAE) v4\] occurring within 30 days of stereotactic radiosurgery (SRS). The non-stratified outcome is reported as the number of DLTs observed in by radiation dose and by strata (Planning Target Volume (PTV) \< 60 cm³ and from 60 to 150 cm³).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
30 days
Results posted on
2021-08-06
Participant Flow
Participant milestones
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform
Baseline characteristics by cohort
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=12 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Age, Continuous
|
72 Years
STANDARD_DEVIATION 5.8 • n=93 Participants
|
61.4 Years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
62.8 Years
STANDARD_DEVIATION 10.0 • n=27 Participants
|
67.1 Years
STANDARD_DEVIATION 8.6 • n=483 Participants
|
65.9 Years
STANDARD_DEVIATION 8.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
6 participants
n=27 Participants
|
12 participants
n=483 Participants
|
30 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Participants receiving each radiotherapy level were stratified by tumor size.
The maximum-tolerated dose (MTD) of study treatment (temozolomid plus hypofractionated radiotherapy administered as 5 fractions) is defined as either: * The highest radiation dose per protocol, or * The radiation dose at which dose-limiting toxicities (DLTs) occurred in ≥ 2 of 3 participants at a dose level, and/or ≥ 2 of 6 participants, at a dose level. Dose-limiting toxicity (DLT) was defined as a treatment-related (with possible, probable or definite attribution) Grade 3 to 5 CNS toxicity \[Common Terminology Criteria for Adverse Events (CTCAE) v4\] occurring within 30 days of stereotactic radiosurgery (SRS). The non-stratified outcome is reported as the number of DLTs observed in by radiation dose and by strata (Planning Target Volume (PTV) \< 60 cm³ and from 60 to 150 cm³).
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=12 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Number of Dose-limiting Toxicities (DLTs)
Planning Target Volume (PTV) < 60 cm³
|
0 Number of DLT observed
|
0 Number of DLT observed
|
0 Number of DLT observed
|
1 Number of DLT observed
|
|
Number of Dose-limiting Toxicities (DLTs)
Planning Target Volume (PTV) 60 to 150 cm³
|
0 Number of DLT observed
|
0 Number of DLT observed
|
0 Number of DLT observed
|
1 Number of DLT observed
|
SECONDARY outcome
Timeframe: 30 daysAcute toxicity is defined as treatment-related adverse events that occur within 30 days of receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each radiotherapy dose level. Acute toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=12 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Number of Acute Toxicity Within 30 Days
CTCAE Grade 1
|
5 adverse events
|
2 adverse events
|
2 adverse events
|
4 adverse events
|
|
Number of Acute Toxicity Within 30 Days
CTCAE Grade 2
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Acute Toxicity Within 30 Days
CTCAE Grade 3
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Acute Toxicity Within 30 Days
CTCAE Grade 4
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
|
Number of Acute Toxicity Within 30 Days
CTCAE Grade 5
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
|
Number of Acute Toxicity Within 30 Days
All grades
|
5 adverse events
|
2 adverse events
|
4 adverse events
|
6 adverse events
|
SECONDARY outcome
Timeframe: 12 monthsLong-term toxicity is defined as treatment-related adverse events (any grade or any Body System) that occur ≥ 30 days after receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each dose level. Long-term toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=12 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Long-term Toxicity After More Than 30 Days
All grades
|
3 Number of adverse events
|
5 Number of adverse events
|
3 Number of adverse events
|
6 Number of adverse events
|
|
Long-term Toxicity After More Than 30 Days
CTCAE Grade 1
|
0 Number of adverse events
|
0 Number of adverse events
|
1 Number of adverse events
|
1 Number of adverse events
|
|
Long-term Toxicity After More Than 30 Days
CTCAE Grade 2
|
0 Number of adverse events
|
1 Number of adverse events
|
1 Number of adverse events
|
1 Number of adverse events
|
|
Long-term Toxicity After More Than 30 Days
CTCAE Grade 3
|
3 Number of adverse events
|
4 Number of adverse events
|
1 Number of adverse events
|
3 Number of adverse events
|
|
Long-term Toxicity After More Than 30 Days
CTCAE Grade 4
|
0 Number of adverse events
|
0 Number of adverse events
|
0 Number of adverse events
|
1 Number of adverse events
|
SECONDARY outcome
Timeframe: 6 monthsRadiographic response rate was assessed following radiotherapy until disease progression. Response is considered to be the sum and proportion participants that achieved a complete response (CR); partial response (PR); or minor response (MR). The outcome is expressed as a number without dispersion for each cohort. CR: Tumor is no longer detected by computed tomography (CT) or magnetic resonance imaging (MRI). PR: Decrease in the product of the two greatest diameters \> 50%, as determined by CT or MRI, with no new lesions, and the same or lower dose of dexamethasone. MR: Decrease in the product of the two greatest diameters \< 50%, as determined by CT or MRI, and neither PR nor PD. PD: New tumor lesion, or \> 25% increase in the product of the two greatest diameters of target lesion, as determined by CT or MRI, provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=12 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Percent of Participants With Radiographic Response
Planning Target Volume (PTV) <60 CM3
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
33.3 Percentage of participants
|
|
Percent of Participants With Radiographic Response
Planning Target Volume (PTV) 60-150CM3
|
66.7 Percentage of participants
|
66.7 Percentage of participants
|
66.7 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 18 Months.Population: Participants who have not progresses and have not reached reached 18 months post-treatment are not included.
Progression-free survival (PFS) following radiotherapy, measured in months. Progressive disease (PD) is defined as: New tumor lesion, or \> 25% increase in the product of the 2 greatest diameters of target lesion, as determined by computed tomography (CT) or magnetic resonance imaging (MRI), provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation. The outcome is expressed as the median with 95% confidence interval for each cohort.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=3 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=3 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=3 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Progression-free Survival
Planning Target Volume (PTV) <60 CM3
|
13.4 Months
Interval 7.6 to 21.5
|
10.5 Months
Interval 8.7 to 11.7
|
33.5 Months
Interval 18.2 to 64.3
|
3.9 Months
Interval 1.7 to 21.2
|
|
Progression-free Survival
Planning Target Volume (PTV) 60-150CM3
|
7.2 Months
Interval 3.2 to 23.3
|
6.5 Months
Interval 2.0 to 9.5
|
8.8 Months
Interval 5.6 to 17.6
|
4.0 Months
Interval 1.7 to 9.2
|
SECONDARY outcome
Timeframe: 20 Months.Overall survival (OS) was assessed as those participants remaining alive with any tumor status following radiotherapy after 20 months. The outcome is stratified by Planning Target Volume (PTV) \< 60 cm³ or 60 to 150 cm³, and expressed as the median value with 95% confidence interval.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=3 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=3 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=3 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Overall Survival (OS)
Planning Target Volume (PTV) <60 CM3
|
17.6 Months
Interval 14.9 to 27.8
|
19.9 Months
Interval 14.8 to 62.4
|
48.3 Months
Interval 33.5 to 64.4
|
10.2 Months
Interval 1.7 to 33.0
|
|
Overall Survival (OS)
Planning Target Volume (PTV) 60-150CM3
|
10.1 Months
Interval 8.7 to 35.4
|
11.3 Months
Interval 10.9 to 16.1
|
17.6 Months
Interval 8.8 to 21.4
|
11.6 Months
Interval 5.3 to 12.7
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated.
European Organization for Research and Treatment of Cancer (EORTC-QLQ C30) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The EORTC-QLQ C30 survey has 30 questions and responses are on scale of 1 to 4 with 1 indicating "not at all" and 4 indicating "very much". The total score can range from 30 to 120. The outcome is stratified by Planning Target Volume (PTV) \< 60 cm³ or 60 to 150 cm³, and is expressed as the mean of the difference from baseline to 12 months, with 95% confidence interval.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=5 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=11 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey
Planning Target Volume (PTV) <60 CM3
|
41.6 score on a scale
Interval -275.9 to 359.3
|
58.3 score on a scale
Interval -16.3 to 132.9
|
80.5 score on a scale
Interval 28.4 to 132.6
|
53.3 score on a scale
Interval 14.2 to 92.4
|
|
Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey
Planning Target Volume (PTV) 60-150CM3
|
41.6 score on a scale
Interval -13.1 to 96.4
|
52.7 score on a scale
Interval 0.68 to 104.8
|
44.4 score on a scale
Interval 20.5 to 68.3
|
51.3 score on a scale
Interval 13.7 to 89.07
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated.
Brain-20 (BN-20) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The Brain-20 (BN-20) quality of life survey has 20 questions and responses are on scale of 1 to 4 with 1 indicating "not at all" (most favorable) and 4 indicating "very much" (least favorable). The total score can range from 20 to 80, and the result is expressed as the difference from baseline (study entry) to 12 months after the start of treatment. The outcome is stratified by Planning Target Volume (PTV) \< 60 cm³ or 60 to 150 cm³, and expressed as the mean with 95% confidence interval.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=5 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=11 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Quality of Life by Brain-20 Survey
Planning Target Volume (PTV) <60 CM3
|
66.6 score on a scale
Interval -356.8 to 490.2
|
40.7 score on a scale
Interval -70.8 to 152.2
|
18.5 score on a scale
Interval -611.1 to 98.1
|
44.4 score on a scale
Interval -8.0 to 96.9
|
|
Quality of Life by Brain-20 Survey
Planning Target Volume (PTV) 60-150CM3
|
40.7 score on a scale
Interval -1.4 to 82.9
|
55.5 score on a scale
Interval -43.9 to 155.0
|
59.2 score on a scale
Interval 1.8 to 116.7
|
25.9 score on a scale
Interval -9.1 to 61.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated.
MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). MDASI-BT quality of life survey has 23 questions and responses are on scale of 0 to 10 with 0 indicating "did not interfere" (most favorable) and 10 indicating "interfered completely" (least favorable). A participant's overall score is computed as the mean of that participant's individual scores, and can range 0 to 10. The outcome is stratified by Planning Target Volume (PTV) \< 60 cm³ or 60 to 150 cm³, and expressed as the mean difference from baseline with 95% confidence interval. A positive value for the mean indicates worsening quality of life.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=4 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=5 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=11 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey
Planning Target Volume (PTV) <60 CM3
|
5.2 score on a scale
Interval -51.9 to 62.4
|
2.0 score on a scale
Interval -23.4 to 27.4
|
2.8 score on a scale
Interval -5.0 to 10.7
|
3.2 score on a scale
Interval 0.2 to 6.3
|
|
Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey
Planning Target Volume (PTV) 60-150CM3
|
3.7 score on a scale
Interval 0.5 to 6.9
|
3.2 score on a scale
Interval -5.1 to 11.6
|
2.3 score on a scale
Interval -3.0 to 7.6
|
3.6 score on a scale
Interval 0.5 to 6.7
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: If the location of a participant's 1st treatment failure could not be determined, then a location assessment relative to any 2nd treatment failure can not done (null result), and for this reason, this analysis only includes participants for whom the location of the 1st treatment failure could be determined.
Treatment failure in individual participants, ie, tumor recurrence or metastasis, can be described by the location relative to the first treatment failure (ie, infield, marginal, or distal), as further defined below. Failure pattern is defined as tumor recurrence or metastasis relative to the primary lesion that is * Infield: at tumor or within 5 mm * Marginal: \> 5 mm or ≤ 20 mm from tumor * Distal: \> 20 mm from tumor The outcome will be reported as the number of participants who failed treatment for each type of failure, ie, infield, marginal, or distal failure.
Outcome measures
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=4 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=11 Participants
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Treatment Failure Analysis
In-Field
|
2 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
|
Treatment Failure Analysis
Marginal
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment Failure Analysis
Distal
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
Serious events: 6 serious events
Other events: 5 other events
Deaths: 5 deaths
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
Serious events: 0 serious events
Other events: 6 other events
Deaths: 4 deaths
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
Serious events: 9 serious events
Other events: 12 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=6 participants at risk
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 participants at risk
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 participants at risk
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=12 participants at risk
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Nervous system disorders
Nervous system disorders-Other, altered mental state
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
25.0%
3/12 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, pulmonary embolism
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, ressection of recurrent tumor
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death
|
66.7%
4/6 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
Other adverse events
| Measure |
Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide
n=6 participants at risk
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide
n=6 participants at risk
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide
n=6 participants at risk
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide
n=12 participants at risk
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
3/12 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
3/6 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
33.3%
4/12 • Number of events 4
|
|
Nervous system disorders
Nervous system disorders -Other, necrosis
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
66.7%
4/6 • Number of events 4
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Nervous system disorders -Other, aphasia
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Tremor
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
Additional Information
Dr. Scott Soltys (Associate Professor of Radiation Oncology)
Stanford University
Phone: 650-724-1569
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place