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OP PRO00038327 SPI_BEL_301 / GROUP 3 CONTROL ARM CHOP	

Types:      Research Oncology Treatment
Synonyms:  BEL-CHOP, SPI_BEL_301

Take-Home Medications	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	predniSONE (DELTASONE) 50 mg tablet	Dose: 100 mg	Route: oral	daily	Dispense: --	Refills: --	Start: S	End: S+5						
Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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, SERUM SCREEN	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Exam
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).
			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
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron solution 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S				  	fosaprepitant (EMEND) 150 mg/100 mL (1.5 mg/mL) IVPB premix 150 mg	Dose: 150 mg	Route: intravenous	once over 20 Minutes for 1 dose	Start: S					Chemotherapy
  	cycloPHOSphamide (CYTOXAN) 750 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 750 mg/m2	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYCLOPHOSPHAMIDE 1 GRAM/50 ML INTRAVENOUS POWDER FOR SOLUTION (RECONSTITUTED VIAL)	Medications	750 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes			  	DOXOrubicin (ADRIAmycin) 50 mg/m2 in sodium chloride 0.9% 50 mL chemo IVPB	Dose: 50 mg/m2	Route: intravenous	once over 10 Minutes for 1 dose			Offset: 1.75 Hours	Instructions:	Protect from light; VESICANT	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DOXORUBICIN 50 MG/25 ML INTRAVENOUS SOLUTION	Medications	50 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	vinCRIStine (ONCOVIN) 1.4 mg/m2 in sodium chloride 0.9% 50 mL chemo IVPB	Dose: 1.4 mg/m2	Route: intravenous	once over 15 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Protect from light, VESICANT: maximum dose 2 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	VINCRISTINE 1 MG/ML INTRAVENOUS SOLUTION	Medications	1.4 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled			Supportive Care
  	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).					
Cycles 2 to 6	Repeat 5 times	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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, SERUM SCREEN	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Exam
			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
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	cycloPHOSphamide (CYTOXAN) 750 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 750 mg/m2	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYCLOPHOSPHAMIDE 1 GRAM/50 ML INTRAVENOUS POWDER FOR SOLUTION (RECONSTITUTED VIAL)	Medications	750 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes			  	DOXOrubicin (ADRIAmycin) 50 mg/m2 in sodium chloride 0.9% 50 mL chemo IVPB	Dose: 50 mg/m2	Route: intravenous	once over 10 Minutes for 1 dose			Offset: 1.75 Hours	Instructions:	Protect from light; VESICANT	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DOXORUBICIN 50 MG/25 ML INTRAVENOUS SOLUTION	Medications	50 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	vinCRIStine (ONCOVIN) 1.4 mg/m2 in sodium chloride 0.9% 50 mL chemo IVPB	Dose: 1.4 mg/m2	Route: intravenous	once over 15 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Protect from light, VESICANT: maximum dose 2 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	VINCRISTINE 1 MG/ML INTRAVENOUS SOLUTION	Medications	1.4 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled			Supportive Care
  	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).					
EOT	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1			Research tolerance: -3/+3 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			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
			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: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
			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
					
LTFollow-up	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1			Research tolerance: -3/+3 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			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
			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: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
			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
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival Status