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RTOG 0933 - "A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases"
NOTES:
1) Site examiners must be credentialed for administering CogState neurocognitive asmts (see Appendix V).
2) Sites that require a laptop to administer the CogState asmt can request one (contact KCCOP). There is a limited supply. Laptops are NOT required to run the CogState software. To receive a laptop, sites must agree to accrue >3 pts/yr to the study.
3) Sites must be approved to administer IMRT on this study (see Section 5.2).
4) Sites & treating investigators must be credentialed for hippocampal contouring & HA-WBRT tx planning (see Section 5.3).
Treatment Plan (Supplied Drug: N/A)
Prior to tx start
1) MRI w/Fused CT Simulation (<30 days pre-regist must have a gadolinium contrast-enhanced MRI showing >1 brain met outside a 5mm margin around either hippocampus - see protocol specifications)
2) Neurocognitive Function Testing
3) QOL Asmt
4) Rapid Central Review of Hippocampal Contours & HA-WBRT Tx Plan (permission to treat or revision request will be returned to investigator w/i 3 business days)
RT
WBRT w/wHippocampal Avoidance using IMRT (30Gy in 10Fx)
Eligibility
Pathologically (histol or cytol) proven dx of non-hematopoietic malignancy other than SC lung or germ cell malignancy w/i 5 yrs pre-regist. If original histol proof of malignancy is >5 yrs, then more recent pathological confirmation is required (i.e., from systemic met or brain met). Mets of unknown prim tumor are allowed.
Must have meas brain mets outside 5mm margin around either hippocampus on gadolinium contrast-enhanced MRI w/i 30 days pre-regist.
If meas brain mets, pt must not have had or plan to have SRS or surgical resection (NOTE: These options are only permitted at relapse).
RTOG recursive partitioning analysis (RPA) Class I or II (see Appendix IV).
>1 wk post-bx (if performed). Requirement does not pertain to stereotactic bxs.
Age >18.
KPS >70.
Men/Women of reproductive potential must use effective contraception.
Women of childbearing potential must have negative, qualitative serum pregnancy test <2 wks pre-study entry.
Must be English proficient. Pts who speak English as a 2nd language are eligible.
No leptomeningeal mets.
No NSCLC-associated brain mets w/>2 organ sites of extracranial mets.
No plan for chemo or targeted therapies during WBRT or over subsequent 7 days.
No contraindication to MRI (i.e., implanted metal devices, foreign bodies, claustrophobia).
No serum creat >1.4mg/dl <30 days pre-study entry.
No prior RT to brain.
No unstable angina &/or CHF requiring hospitalization w/i last 6 mos; no transmural MI w/i last 6 mos; no acute bacterial or fungal infection requiring IV antibiotics at regist; no hepatic insufficiency resulting in clinical jaundice &/or coagulation defects; no COPD exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at regist; no uncontrolled, clinically significant cardiac arrhythmias; no radiologic evidence of hydrocephalus.
PRESTUDY REQUIREMENTS:
Histol/Cytol eval (w/i 5 yrs pre-regist)
H&P, perf status*
Serum creat*
Serum pregnancy test (if applicable)**
Gadolinium contrast-enhanced brain MRI*
Head CT simulation scan**
HA-WBRT tx plans**
Serum, plasma, whole blood for banking/translational research (w/pt's consent - prior to HA-WBRT)***
* Within 30 days pre-regist
** Within 2 wks prior to initiating tx
*** Serum (5-10mL whole blood in 2 red top tubes), plasma (5-10mL anticoagulated whole blood in EDTA tube #1 [purple/lavender top]), & DNA (5-10mL anticoagulated whole blood in EDTA tube #2 [purple/lavender top]). Process per protocol & ship frozen on dry ice via overnight carrier (send Mon-Wed only) to: RTOG Biospecimen Resource; San Francisco, CA.