PhIII TrialSingFractionStereotacticRadiosurgVSFractionatedSRS IntactBrainMets
Study Description
Imaging Timing: The MRI used for SRS or FSRS planning should at least include a
post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled
gradient (SPGR). Acceptable 3D SPGR sequences include magnetization-prepared 3D
gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE)
MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted
3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm.
The MRI used for treatment planning must be within 7 calendar days from start of SRS
or FSRS (a variation acceptable is 1 additional calendar day, beyond this would be
considered an unacceptable deviation). If an additional MRI is obtained for treatment
planning it only needs to include the post-gadolinium contrast-enhanced sequence with
an axial slice thickness, not to exceed 1.5 mm.
Treatment Timing: Patients must initiate radiosurgery treatment ≤14 days after
randomization. Treatment should start within 7 days of the MRI used for treatment
planning. All patients treated with FSRS will be treated on consecutive days (excluding
weekends, legal holidays, machine failure, or other reason the department is closed).
Cytotoxic chemotherapy should not be administered the same day(s) as the SRS / FSRS
(see section 5.2.1). For any questions regarding systemic therapy timing with
SRS/FSRS, please contact the PI or the Medical Oncology Chair.
The MRI used for registration in the clinical trial as well as the MRI used for treatment
planning as well as the radiosurgery treatment plan and structure set should be uploaded
to TRIAD, see section 14.2.
Eligibility
Pathologically (histologically or cytologically) proven diagnosis of one of the following
solid tumor malignancies within 5 years prior to registration
- non-small cell lung cancer
- melanoma
- breast cancer
- renal cell carcinoma
- gastrointestinal cancer
Definition of Disease
- Patients must have at least 1 and up to 8 total intact brain metastases detected on a
contrast-enhanced MRI (see Appendix I for imaging guidelines) performed ≤ 21
days prior to registration.
- At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion
with a maximum diameter as measured on any orthogonal plane (axial, sagittal,
coronal) of equal or >1.0 cm and equal or < 3.0 cm.
- All brain metastases must be located outside of the brainstem and ≥5 mm from the
optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension.
Note: brainstem metastases per the MRI within 21 days of registration are
an exclusion criterion; however, if the MRI used for treatment planning
performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the
patient remains eligible if the patient is considered an appropriate
radiosurgery candidate per the local investigator.
- Patients must have a diagnosis-specific graded prognostic assessment ≥1.5 (see
Appendix II).
- No more than 2 lesions planned for resection if clinically indicated
- No known leptomeningeal disease (LMD)
Age equal or >18 years
Karnofsky performance status (KPS) equal or >60
Negative urine or serum pregnancy test (in persons of childbearing potential) within 14
days prior to registration. Childbearing potential is defined as any person who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy) or who is not postmenopausal
No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or
prophylactic cranial irradiation [PCI])
New York Heart Association Functional Classification II or better (NYHA Functional
Classification III/IV are not eligible) (Note: Patients with known history or current
symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should
have a clinical risk assessment of cardiac function using the New York Heart
Association Functional Classification);
- No active infection currently requiring IV antibiotic management;
- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
- No chronic obstructive pulmonary disease exacerbation or other acute respiratory
illness precluding study therapy
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