Trial Outcomes & Findings for Phase II Study of Gamma Knife Radiosurgery and Temozolomide for Brain Metastases (NCT NCT00582075)
NCT ID: NCT00582075
Last Updated: 2023-03-27
Results Overview
Patients developing distant brain failure (DBF) at one year. An approximation method was used to arrive at the reported percentage.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
1 years
Results posted on
2023-03-27
Participant Flow
Participant milestones
| Measure |
Radiosurgery 15-24 Gy + Adjuvant Temozolomide
Patients with newly diagnosed brain mets treated with radiosurgery.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Gamma Knife Radiosurgery and Temozolomide for Brain Metastases
Baseline characteristics by cohort
| Measure |
Radiosurgery 15-24 Gy + Adjuvant Temozolomide
n=25 Participants
Patients with newly diagnosed brain mets treated with radiosurgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Age, Continuous
|
56 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 yearsPatients developing distant brain failure (DBF) at one year. An approximation method was used to arrive at the reported percentage.
Outcome measures
| Measure |
Radiosurgery 15-24 Gy + Adjuvant Temozolomide
n=25 Participants
Patients with newly diagnosed brain mets treated with radiosurgery.
|
|---|---|
|
Percentage of Participants With Distant Brain Failure (DBF) at One Year
|
37 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Radiosurgery 15-24 Gy + Adjuvant Temozolomide
n=25 Participants
Patients with newly diagnosed brain mets treated with radiosurgery.
|
|---|---|
|
Overall Survival
|
31 weeks
Interval 11.0 to 104.0
|
Adverse Events
Radiosurgery 15-24 Gy + Adjuvant Temozolomide
Serious events: 15 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiosurgery 15-24 Gy + Adjuvant Temozolomide
n=25 participants at risk
Patients with newly diagnosed brain mets treated with radiosurgery.
|
|---|---|
|
Vascular disorders
DVT
|
12.0%
3/25
|
|
Musculoskeletal and connective tissue disorders
Broken Hip
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.0%
2/25
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
4.0%
1/25
|
|
Cardiac disorders
Death
|
4.0%
1/25
|
|
Nervous system disorders
Seizures
|
4.0%
1/25
|
|
Surgical and medical procedures
Surgical Revision of Necrotic Tissue
|
8.0%
2/25
|
|
Gastrointestinal disorders
Hemorrhage (GI)
|
4.0%
1/25
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25
|
|
Nervous system disorders
Altered Mental Status
|
8.0%
2/25
|
Other adverse events
| Measure |
Radiosurgery 15-24 Gy + Adjuvant Temozolomide
n=25 participants at risk
Patients with newly diagnosed brain mets treated with radiosurgery.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
64.0%
16/25
|
|
Blood and lymphatic system disorders
Lymphopenia
|
56.0%
14/25
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
48.0%
12/25
|
|
Blood and lymphatic system disorders
Anemia
|
44.0%
11/25
|
|
Investigations
Hypoalbuminemia
|
48.0%
12/25
|
|
Blood and lymphatic system disorders
Decreased White Blood Cell Count
|
40.0%
10/25
|
|
Investigations
Hyperkalemia
|
8.0%
2/25
|
|
Gastrointestinal disorders
Constipation
|
32.0%
8/25
|
|
Investigations
Increased ALT
|
32.0%
8/25
|
|
General disorders
Fever
|
12.0%
3/25
|
|
Investigations
Hyponatremia
|
20.0%
5/25
|
|
Investigations
Hypocalcemia
|
12.0%
3/25
|
|
Nervous system disorders
Confusion
|
16.0%
4/25
|
|
General disorders
Fatigue
|
44.0%
11/25
|
|
Investigations
Hypoglycemia
|
8.0%
2/25
|
|
Gastrointestinal disorders
Nausea
|
40.0%
10/25
|
|
Investigations
Hypokalemia
|
8.0%
2/25
|
|
Investigations
Hypernatremia
|
8.0%
2/25
|
|
Investigations
Increased Bilirubin
|
12.0%
3/25
|
|
Nervous system disorders
Headache
|
40.0%
10/25
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
5/25
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
5/25
|
|
Nervous system disorders
Vision Alteration
|
16.0%
4/25
|
|
General disorders
Dizziness
|
24.0%
6/25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
2/25
|
|
Nervous system disorders
Ataxia
|
8.0%
2/25
|
|
Investigations
Increased GGT
|
8.0%
2/25
|
|
Blood and lymphatic system disorders
Decreased ANC
|
16.0%
4/25
|
|
Investigations
Increased AST
|
12.0%
3/25
|
|
General disorders
Weakness
|
8.0%
2/25
|
|
Nervous system disorders
Vertigo
|
8.0%
2/25
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
5/25
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
3/25
|
|
Nervous system disorders
Neuropathy - Motor
|
8.0%
2/25
|
|
Injury, poisoning and procedural complications
Radionecrosis
|
8.0%
2/25
|
|
General disorders
Anorexia
|
8.0%
2/25
|
|
Nervous system disorders
Syncope
|
8.0%
2/25
|
|
Nervous system disorders
Neuropathy - Sensory
|
8.0%
2/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place