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RESEARCH PRO00020627 ZAID NRG-GY006 ARM 1	

Types:      Research Oncology Treatment
Synonyms:  PRO20627, 20627, VAGINAL, UTERINE CERVIX

Baseline	Repeat 1 time	Cycle length: 28 days	28 Days Prior to Registration	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History and Physical examination (including initial clinical tumor measurement in centimeters)
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Pain Scale
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	GOG Performance Status
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Smoking History Questionnaire
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	PET CT SKULL BASE TO MID THIGH	Interval: --	Occurrences: --				14 Days Prior to Registration	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Toxicity Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Obtain Concurrent Medications Information
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --				7 Days Prior to Registration	Perform every 1 day x1		Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --				Prior to First  Radiation Treatment	Perform every 1 day x1		Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --					
Cycle 1	Repeat 1 time	Cycle length: 67 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History and Physical examination
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Toxicity Assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Encourage patient to increase oral intake of fluid 24 hours prior to Cisplatin infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Daily Pelvic external beam radiation therapy 
o Excludes weekends and holidays 
o Start on a Monday is preferred 
o Antiemetic and anti-diarrheal medication may be administered as needed 
o For EBRT, the prescription dose is 45 Gy in 25 fractions at 1.8 Gy/fraction with an optional parametrial boost of 5.4 Gy in three fractions at 1.8 Gy/fraction. EBRT should be given once daily Monday-Friday, 5 fractions per week 
o For IMRT, the prescription dose is 45 Gy in 25 fractions at 1.8 Gy/fraction, unless a simultaneous integrated boost (SIB) is required for gross nodal disease. For SIB cases, the primary target will receive 47.6 Gy in 1.7 Gy/fraction and the gross nodal PTV (PTV_Boost) will receive 1.93-2.12 Gy per fraction, depending on bowel tolerance. IMRT should be given once daily Monday-Friday, 5 fractions per week
			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Daily Pelvic brachytherapy 
o Excludes weekends and holidays 
o Start on a Monday is preferred 
o Antiemetic and anti-diarrheal medication may be administered as needed
o The prescription doses are 27.5 - 30 Gy for HDR and 35 - 40 Gy for LDR, following institutional protocol
			Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	General Concomitant Medication and Supportive Care Guidelines:
o Because it has been observed that hemoglobin levels below 10-12 g/dL during radiotherapy are associated with decreased local control, blood transfusions should be offered to and used to treat patients at the discretion of treating physicians prior to or during radiotherapy. There should be no radiotherapy treatment delays due to a low hemoglobin levels.

o Loperamide will be recommended during the study in order to prevent diarrhea that may ultimately lead to intravenous infusion of fluids or hospitalizations.  For the administration of loperamide, it is recommended that patients take two (2) caplets (4 mg) at the first sign of diarrhea. Patients should continue taking one (1) caplet (2 mg) every two hours until they return to their normal pattern of bowel movements. They may repeat same doses and frequency if diarrhea returns. During the night, patients may take two (2) caplets every four hours rather than one (1) every two hours. Patients should call their doctor if they have any questions about taking loperamide, if they believe they are not achieving adequate control of diarrhea, or if they are feeling extremely weak, lightheaded, or dizzy (symptoms of dehydration). Side effects of loperamide include tiredness, drowsiness, or dizziness. If they experience these side effects, they should avoid driving a motorized vehicle or 
operating machinery. Before using any laxative, patients should consult their physician. Patients should make an extra effort to drink lots of fluids (several glasses of water, fruit juices, soda, soup, etc.) every day while they participate in this study.
				Days 2,9,16,23,30	Perform every 7 days x5		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	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.			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 2	Interval: --	Occurrences: --	Comments:	History and Physical examination
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Toxicity Assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Encourage patient to increase oral intake of fluid 24 hours prior to Cisplatin infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Cisplatin dose modification:
o Hematologic treatment decisions will be based on the absolute neutrophil count (ANC) on day of treatment or no greater than 72 hours prior to planned treatment. No cisplatin will be administered unless pre-treatment counts demonstrate an ANC GREATER than OR EQUAL to 1,500/ uL and platelet count is GREATER than OR EQUAL to 75,000 / uL. Chemotherapy will be held until these values are exceeded. External radiation should continue while chemotherapy is being held. 
Cisplatin: 
o Starting Dose Level:  40 mg/m2 
o 25% Reduction Dose Level:  30 mg/m2
			Pre-Hydration
  	sodium chloride 0.45 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once over 1 Hours for 1 dose	Start: S			Instructions:	Infuse one hour before cisplatin			Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Medications
☑	dexamethasone (DECADRON) IV 10-20 mg	Dose: 10-20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Dexamethasone 10-20 mg IV is allowed as an optional pre-medication. Administer 30 minutes before chemotherapy			Chemotherapy
  	CISplatin (PLATINOL) 40 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 40 mg/m2	Route: intravenous	once over 90 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Caution Chemotherapy: Handle and dispose per chemotherapy/cytotoxic policy. Store at room temperature. Protect from light. Irritant precaution. If extravasates, consult pharmacist. 

Preferably adminitered before, but allowed to be after pelvic radiation treatment	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	40 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	250 mL	Always	Yes				Post-Hydration
  	sodium chloride 0.45 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once over 1 Hours for 1 dose			Offset: 3 Hours	Instructions:	Infused over one hour after cisplatin infusion			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.				Day 37	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	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.			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 32	Interval: --	Occurrences: --	Comments:	o Assessments must be completed even if optional cisplatin on day 37 is not given 
o Cisplatin to be administered at the treating physician's discretion
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History and Physical examination
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Toxicity Assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Encourage patient to increase oral intake of fluid 24 hours prior to Cisplatin infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Cisplatin dose modification:
o Hematologic treatment decisions will be based on the absolute neutrophil count (ANC) on day of treatment or no greater than 72 hours prior to planned treatment. No cisplatin will be administered unless pre-treatment counts demonstrate an ANC GREATER than OR EQUAL to 1,500/ uL and platelet count is GREATER than OR EQUAL to 75,000 / uL. Chemotherapy will be held until these values are exceeded. External radiation should continue while chemotherapy is being held. 
Cisplatin: 
o Starting Dose Level:  40 mg/m2 
o 25% Reduction Dose Level:  30 mg/m2
			Pre-Hydration
  	sodium chloride 0.45 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once over 1 Hours for 1 dose	Start: S			Instructions:	Infuse one hour before cisplatin			Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Medications
☑	dexamethasone (DECADRON) IV 10-20 mg	Dose: 10-20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Dexamethasone 10-20 mg IV is allowed as an optional pre-medication. Administer 30 minutes before chemotherapy			Chemotherapy
  	CISplatin (PLATINOL) 40 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 40 mg/m2	Route: intravenous	once over 90 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Caution Chemotherapy: Handle and dispose per chemotherapy/cytotoxic policy. Store at room temperature. Protect from light. Irritant precaution. If extravasates, consult pharmacist. 

Preferably adminitered before, but allowed to be after pelvic radiation treatment	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	40 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	250 mL	Always	Yes				Post-Hydration
  	sodium chloride 0.45 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once over 1 Hours for 1 dose			Offset: 3 Hours	Instructions:	Infused over one hour after cisplatin infusion			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.					
Follow Up From end of treatment: 1 month	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Obtain Medical History
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	GOG Performance Status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Vital Status (including any recurrence)
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Toxicity Assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --					
Follow Up From end of treatment: 3 month	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Obtain Medical History
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	GOG Performance Status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Vital Status (including any recurrence)
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Toxicity Assessment
			Labs
  	GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Obtain Glucose Level Prior to PET / CT
		  	BUN LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --			Imaging
  	PET CT SKULL BASE TO MID THIGH	Interval: --	Occurrences: --					
Long Term Follow Up Year 1 and 2	Repeat 5 times	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Obtain Medical History
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	ECOG Performanace Status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Vital Status (including any recurrence)
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Toxicity Assessment
					
Long Term Follow Up Year 3, 4, and 5	Repeat 6 times	Cycle length: 180 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Obtain Medical History
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	ECOG Performanace Status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Vital Status (including any recurrence)
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Toxicity Assessment