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OP RSH PRO00046557 S1800E IND 143217 ZHANG SCREENING ARM	

Types:      Research Oncology Treatment
Synonyms:  PRO00046557 SWOG

PRE REGISTRATION	Repeat 1 time	Cycle length: 180 days	Within 6 Months	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	See Section 5.3 for details.
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	See Section 5.3 for details.
		  	HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	See Section 5.3 for details.
				Within 42 days	Perform every 1 day x1			Research tolerance: -0/+0 days	Imaging
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brain CT or MRI is required per Section 5.1. If participant has brain metastases at baseline, brain scans must use the same modality as baseline and be repeated at least every 12 weeks (± 7 days) regardless of treatment delays, while on treatment. If participant has brain metastases at baseline, continue brain CT or MRI scans (same modality as baseline) after off protocol treatment prior to progression, as clinically indicated. For alignment with the protocol and good clinical practice, recommended frequency of brain scans after off protocol treatment (and prior to progression) is at least every 12 weeks, unless more frequent scans are clinically appropriate.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
		☐	CT HEAD WO CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
		☑	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
		☐	MRI BRAIN WO CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
				28 days prior to randomization	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   S1800E_Zhang
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for: Refer to Section 8.3
Protocol Access Hyperlink:   S1800E_Zhang[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	History & Physical Exam
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Performance Status
		  	DAILY WEIGHTS	Interval: --	Occurrences: --			Imaging
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	CT or MRI for Disease Assessment. CT or MRI (the same method used at pre-study to meet the eligibility criteria in Section 5.1) must be repeated every 6 weeks (± 7 day window) for the first year, regardless of treatment delays, then every 12 weeks until disease progression and discontinuation of protocol treatment. The 6 weeks starts from randomization. If the participants remains on protocol treatment after progression due to clinical benefit (per Section 7.6a), scans must continue per protocol schedule (per Section 7.3) until treatment is discontinued. If the participant is removed from protocol treatment prior to progression, scans must continue per protocol schedule until progression.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Chemistry panel must include standard of care calculated creatinine clearance, and liver function tests (total bilirubin, AST, ALT). If labs obtained w/in 14 days prior to tx, tests need not be repeated on C1D1.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If labs obtained w/in 14 days prior to tx, tests need not be repeated on C1D1.
		  	PROTEIN, URINALYSIS	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Buffy Coat / Plasma for Banking.With participant's consent, additional research blood draws will be collected per Section 15.4. Submission must be after sub-study registration. Do not collect and ship prior to sub-study registration.