Trial Outcomes & Findings for Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases (NCT NCT00587964)
NCT ID: NCT00587964
Last Updated: 2016-02-22
Results Overview
following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI. No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease.
COMPLETED
PHASE2
51 participants
1 year
2016-02-22
Participant Flow
Participant milestones
| Measure |
Treatment - Stereotactic Radiosurgery
Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Treatment - Stereotactic Radiosurgery
Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Patient found to be ineligible
|
1
|
|
Overall Study
Patient did not receive intervention
|
5
|
|
Overall Study
Progression of Disease
|
4
|
Baseline Characteristics
Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
Baseline characteristics by cohort
| Measure |
Treatment - Stereotactic Radiosurgery
n=51 Participants
Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearfollowing a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI. No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease.
Outcome measures
| Measure |
Treatment - Stereotactic Radiosurgery
n=39 Participants
Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
|
|---|---|
|
Local Control
Local Control
|
13 participants
|
|
Local Control
No Evidence of Disease (NED)
|
23 participants
|
|
Local Control
Progression of Disease (POD)
|
2 participants
|
|
Local Control
Relapse/Recurrence
|
1 participants
|
Adverse Events
Treatment - Stereotactic Radiosurgery
Serious adverse events
| Measure |
Treatment - Stereotactic Radiosurgery
n=51 participants at risk
Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Confusion
|
5.9%
3/51 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Number of events 1
|
|
General disorders
General symptom
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Radiation oesophagitis
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Headache
|
2.0%
1/51 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Number of events 2
|
|
Nervous system disorders
Neurological disorder
|
3.9%
2/51 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/51 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets count decrease
|
2.0%
1/51 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.9%
2/51 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
5.9%
3/51 • Number of events 3
|
|
Nervous system disorders
Seizure
|
3.9%
2/51 • Number of events 3
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • Number of events 1
|
|
Cardiac disorders
Thrombosis
|
2.0%
1/51 • Number of events 1
|
|
Eye disorders
Vision-blurred vision
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
2/51 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kathryn Beal
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place