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OP RESEARCH PRO00038369 / HMCC-GI24-001 SCREENING / BASELINE	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, BASELINE, METASTATIC COLORECTAL CANCER

Screening	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	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:  HMCC-GI24-001_Abdelrahim
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Regorafenib Refer to Section XXX Protocol Access Hyperlink:  HMCC-GI24-001_Abdelrahim
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion Criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG will be assessed at each physical exam timepoint.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exams will be performed at screening or baseline, before every cycle, and at EOT. A neurological exam will be conducted during each physical exam. Height will be measured at screening only. Weight will be measured at each physical exam timepoint.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs will be performed at screening or baseline, before every cycle, and at EOT. Vital signs include (blood pressure, oral temperature, heart rate, and respiratory rate) measurements. Blood pressure will be evaluated every week for the first 6 weeks of treatment to monitor for hypertension
			Procedures
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT scan of the chest, abdomen, and pelvis with contrast will be performed at screening, cycle 3, cycle 6, cycle 9, and at EOT
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Electrocardiography (ECG) will be performed at screening and when clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Tissue biopsy (optional) refers to patients signed voluntary consent forms, and tissue archival (if applicable). A total of 11 slides will be utilized for tissue collection.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Tumor assessment will be measured according to RECIST v1.1 criteria and reviewed by the investigator based on imaging.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PT AND PTT	Interval: --	Occurrences: --					
Baseline	Repeat 1 time	Cycle length: 7 days	Day -7	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	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:  HMCC-GI24-001_Abdelrahim
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Regorafenib Refer to Section XXX Protocol Access Hyperlink:  HMCC-GI24-001_Abdelrahim
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	The EORTC QLQ-C30 Questionnaire is to be administered at baseline, cycle 6, and EOT visit. Patients will complete the EORTC QLQ-C30 questionnaires prior to infusion at treatment visits.
			Labs
  	CARCINOEMBRYONIC ANTIGEN (CEA)	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential, the results of a serum B-hCG pregnancy test must be negative within 7 days prior to the administration of the first dose of study treatment. If the screening serum B-hCG pregnancy test is performed more than 7 days before dosing, it must be repeated at baseline, with results known to be negative prior to the administration of the first dose of study treatment. Serum B-hCG pregnancy testing is to be performed as clinically indicated