Status:
TERMINATED
Preoperative SRS/SRT vs Postoperative SRS/SRT for Brain Metastases
Lead Sponsor:
University of Arkansas
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial conducted at a single study site (UAMS). Subjects will be randomized to one of the 2 treatment arms and st...
Eligibility Criteria
Inclusion
- Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
- MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
- Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate both surgery and SRS/SRT, e.g., the ability to lie flat in a stereotactic soft head frame.
- ECOG ≤ 2
- 1-2 index lesion(s) appropriate for resection, not previously treated with SRS/SRT.
- Index lesion(s) should be \> 2 cm and \< 5 cm in largest dimension, and require resection. Alternatively, patients with a diagnosis of melanoma and a lesion \< 1.5cm in largest dimension may also be included. o All other brain lesions must be appropriate for SRS/SRT alone and treated according to physician preference. Prior neurosurgery and/or prior SRS/SRT at a non-overlapping location are permitted at the discretion of the treating physician.
- \- MRI confirmed 1-10 lesions, 1-2 of which are the index lesions undergoing surgery.
- Each non-index lesion (up to 10) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection.
- Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (≤ 10 metastases).
- Surgical resection able to be performed within 15 days of radiotherapy completion.
- Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study.
- Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of radiation. WOCBP is a female patient less than 50 years of age or who has menstruated within the last 12 months.
- Platelet count \> 80 k/cumm, Hgb \> 7.5 gm/dL, INR \< 1.3, ANC \> 1.5 k/cumm
Exclusion
- Not a surgical candidate per neurosurgeon's discretion.
- Contraindication to general anesthesia.
- Not a radiosurgical candidate per radiation oncologist's discretion.
- Metastatic germ cell tumor, small cell carcinoma, leukemia, multiple myeloma or lymphoma or any primary brain tumor
- ECOG \> 2
- \< 3 months expected survival
- Radiologic documentation of hydrocephalus in addition to symptoms of hydrocephalus
- Radiographic or cytologic evidence of leptomeningeal disease.
- Imaging Findings:
- Midline shift \> 6mm
- \>10 lesions, one of which is the index lesion
- Largest lesion \> 5cm
- Pregnancy
- Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants are eligible.
- Patients who have local recurrence of previously treated brain metastasis.
- Patients who have received prior WBRT.
- Inherited radiation hypersensitivity syndromes
- o Ataxia Telangiectasia, Nijmegen Breakage Syndrome, Fanconi Anemia, DNA Ligase IV, Mre 11 deficiency, SCID, Bloom's syndrome
- Collagen vascular diseases
- o Active systemic lupus erythematous (SLE), scleroderma, mixed connective tissue disorder, polymyositis or dermatomyositis, CREST Syndrome
- Cytotoxic Chemotherapy within 7 days prior to SRS/SRT.
- o Molecularly targeted therapies, including immune-modulatory drugs, can be given within 7 days of SRS/SRT at the discretion of the treating physician.
- Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection.
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04422639
Start Date
August 24 2020
End Date
March 27 2023
Last Update
July 28 2023
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72223