Trial Outcomes & Findings for Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy (NCT NCT05718466)
NCT ID: NCT05718466
Last Updated: 2023-07-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
2 months
Results posted on
2023-07-17
Participant Flow
Participant milestones
| Measure |
Fractionated Radiosurgery and Bevacizumab
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
Fractionated radiosurgery
|
Bev With Chemo
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Fractionated Radiosurgery and Bevacizumab
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
Fractionated radiosurgery
|
Bev With Chemo
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fractionated Radiosurgery and Bevacizumab
n=18 Participants
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
Fractionated radiosurgery
|
Bev With Chemo
n=17 Participants
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 16.3 • n=18 Participants
|
59.2 years
STANDARD_DEVIATION 8.3 • n=17 Participants
|
55.2 years
STANDARD_DEVIATION 13.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=18 Participants
|
11 Participants
n=17 Participants
|
25 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Diagnosis
Anaplastic astrocytoma
|
2 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
4 Participants
n=35 Participants
|
|
Diagnosis
Anaplastic oligodendroglioma
|
0 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
|
Diagnosis
Glioblastoma
|
16 Participants
n=18 Participants
|
13 Participants
n=17 Participants
|
29 Participants
n=35 Participants
|
|
Neoadjuvant RT Dose
54
|
0 Participants
n=18 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=35 Participants
|
|
Neoadjuvant RT Dose
59.4
|
1 Participants
n=18 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
|
Neoadjuvant RT Dose
60
|
17 Participants
n=18 Participants
|
15 Participants
n=17 Participants
|
32 Participants
n=35 Participants
|
|
Neoadjuvant Chemotherapy
|
16 Participants
n=18 Participants
|
17 Participants
n=17 Participants
|
33 Participants
n=35 Participants
|
|
On-Trial Chemotherapy
BEV+Carboplatin
|
15 Participants
n=18 Participants
|
11 Participants
n=17 Participants
|
26 Participants
n=35 Participants
|
|
On-Trial Chemotherapy
BEV+etoposide
|
1 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=35 Participants
|
|
On-Trial Chemotherapy
BEV+irinotecan
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
On-Trial Chemotherapy
BEV+temozolomide
|
1 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=35 Participants
|
|
On-Trial Chemotherapy
No trial chemotherapy
|
1 Participants
n=18 Participants
|
4 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 monthsOutcome measures
| Measure |
Fractionated Radiosurgery and Bevacizumab
n=17 Participants
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
Fractionated radiosurgery
|
Bev With Chemo
n=15 Participants
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
|
|---|---|---|
|
Local Tumor Control
|
14 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Fractionated Radiosurgery and Bevacizumab
n=18 Participants
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
Fractionated radiosurgery
|
Bev With Chemo
n=17 Participants
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
|
|---|---|---|
|
Overall Survival
|
7.2 months
Interval 6.1 to 8.1
|
4.8 months
Interval 1.7 to 7.6
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Fractionated Radiosurgery and Bevacizumab
n=18 Participants
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
Fractionated radiosurgery
|
Bev With Chemo
n=17 Participants
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
|
|---|---|---|
|
Progression Free Survival
|
5.1 months
Interval 4.1 to 6.2
|
1.8 months
Interval 1.2 to 2.8
|
Adverse Events
Fractionated Radiosurgery and Bevacizumab
Serious events: 5 serious events
Other events: 0 other events
Deaths: 15 deaths
Bev With Chemo
Serious events: 4 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Fractionated Radiosurgery and Bevacizumab
n=18 participants at risk
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
Fractionated radiosurgery
|
Bev With Chemo
n=17 participants at risk
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.6%
1/18
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
5.6%
1/18
|
0.00%
0/17
|
|
General disorders
Nausea/Vomiting
|
5.6%
1/18
|
0.00%
0/17
|
|
General disorders
New Onset Weakness
|
5.6%
1/18
|
0.00%
0/17
|
|
Nervous system disorders
Seizure
|
5.6%
1/18
|
0.00%
0/17
|
|
Nervous system disorders
Cerebral Edema
|
0.00%
0/18
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/18
|
5.9%
1/17
|
|
Nervous system disorders
Altered Mental Status
|
0.00%
0/18
|
5.9%
1/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intratumoral Hemorrhage
|
0.00%
0/18
|
5.9%
1/17
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place