Protocol Index	

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OP PRO00038327 SPI_BEL_301 / SCREENING	

Types:      Research Oncology Treatment
Synonyms:  BASELINE, SCREENING, SPI_BEL_301, PERIPHERAL T-CELL LYMPHOMA (PTCL)

Baseline/Screening( up to 28 days)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Tumor Assessment Via CT or MRI is required.
PET Scan Required
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Tumor assessments will be performed every 3 cycles (i.e., every 9 weeks); on Cycle 4 Day 1 and End-of-Treatment Visit, and patients will be followed for progression with a computed tomography (CT; or MRI, if CT is not possible) scan every 3 months for 3 years for patients with CR, PR, or stable disease (SD) and every 6 months thereafter and will be followed for survival every 6 months by phone for up to 10 years
			Nursing Orders
  	CONSENT OBTAINED	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Medical History and current medical conditions.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PIT score calculation
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Exam
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications review.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	PET CT SKULL BASE MID THIGH EXTERNAL STUDY	Interval: --	Occurrences: --			Imaging
  	CT SOFT TISSUE NECK W CONTRAST	Interval: --	Occurrences: --			Imaging
  	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --			Imaging
  	MRI FACE NECK ORBIT W WO CONTRAST	Interval: --	Occurrences: --		  	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --		  	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		  	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --