Description:
This is a prospective, single arm, phase II trial to determine the local control at 6 months
utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 4 days in
subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical
resection of at least one brain metastasis at the discretion of a neurosurgeon.
Title
- Brief Title: Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases
- Official Title: A Phase II Study Analyzing Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With 1 - 4 Brain Metastases
Clinical Trial IDs
- ORG STUDY ID:
IUSCC-0627
- SECONDARY ID:
1707314702
- NCT ID:
NCT03398694
Conditions
Purpose
This is a prospective, single arm, phase II trial to determine the local control at 6 months
utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 4 days in
subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical
resection of at least one brain metastasis at the discretion of a neurosurgeon.
Detailed Description
Primary Objective To evaluate 6 month in-brain local control utilizing pre-operative
stereotactic radiosurgery followed by surgical resection for brain metastases.
Secondary Objectives
- Overall survival
- Distant in-brain progression
- Rate of leptomeningeal spread
- Rate of radiation necrosis
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1 | Experimental | This is a single arm study so this arm will include all eligible subjects. All subjects will have radiosurgery 1-4 days prior to surgical resection. | |
Eligibility Criteria
Inclusion Criteria
1. Radiographically confirmed solid tumor brain metastases
2. Criteria for surgical resection of at least one metastasis per neurosurgeon discretion
3. A diagnostic MRI Brain or CT Head demonstrating the presence of 1-4 solid tumor brain
metastases and lesion to be resected no more than 5 cm in any direction, performed
within 30 days prior to stereotactic radiosurgery. If multiple lesions are present,
then the total brain metastases volume can be no more than 30 cm3 excluding the lesion
to be resected.
4. For known primary included in brainmetgpa.com, an estimated median survival no less
than 6 months per brainmetgpa.com
5. For unknown primary or known primary not included within brainmetgpa.com, an estimated
median survival no less than 6 months per PI discretion Note: If patient's estimated
median survival is calculated using a histology that is different than the histology
demonstrated in final pathology, the patient may remain eligible for all study
endpoints per PI discretion
6. Surgical candidate per neurosurgeon discretion
7. Surgical resection able to be performed within 1 - 4 days after radiosurgery
8. Stereotactic radiosurgery candidate per radiation oncologist
9. ≥ 18 years old at the time of informed consent
10. Ability to provide written informed consent and HIPAA authorization. This will be
assessed by the consenting physician using general questions to determine the
patient's ability to understand the medical problem, proposed treatment, alternatives
to proposed treatment, and understand the consequences of the medical choices.
11. Platelet count > 100 k/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm
12. Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not
including anti-VEGF therapy
13. If a patient who meets all stated eligibility criteria is enrolled on study and then
discovered to be ineligible, the tissue obtained will still be deemed eligible to
remain in study for evaluation.
Exclusion Criteria
1. Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there
is increased risk of fatal brain hemorrhage with surgical resection
2. Major medical illnesses or psychiatric impairments, which in the investigator's
opinion will prevent administration or completion of the protocol therapy and/or
interfere with follow-up
3. Patients with more than 4 brain metastases on MRI Brain or CT Head
4. Lesion to be resected is more than 5 cm
5. Total volume of metastatic disease more than 30 cm3 excluding lesion to be resected
6. Patients with leptomeningeal metastases documented by MRI or CSF evaluation
7. Previous whole brain radiation therapy
8. Previous radiation therapy to lesion to be resected
9. Planned adjuvant focal therapy including additional radiation therapy to the brain
10. Not a surgical candidate per neurosurgeon's discretion
11. Not a radiosurgical candidate per radiation oncologist's discretion
12. Surgery unable to be performed between 1 - 4 days after radiosurgery
13. Women who are pregnant or nursing are not eligible as treatment involves unforeseeable
risks to the fetus or child
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of local control of any new, recurrent, or progressing tumors within the planning target volume |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Measured by post-treatment MRI |
Secondary Outcome Measures
Measure: | Rate of overall survival |
Time Frame: | 6 months, 1 year, and 2 years |
Safety Issue: | |
Description: | Time from start of treatment to death of any cause |
Measure: | Rate of in-brain progression free survival |
Time Frame: | 6 months, 1 year, and 2 years |
Safety Issue: | |
Description: | Time from start of treatment to any in-brain |
Measure: | Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Measured by post-treatment MRI |
Measure: | Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Measured by post-treatment MRI |
Measure: | Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Measured by post-treatment MRI |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Indiana University |
Last Updated
June 4, 2021