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OP RESEARCH PRO00039815 / HMCC-GI25-001 SCREENING / BASELINE	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, BASELINE

Screening / Baseline	Repeat 1 time	Cycle length: 28 days	Day -28 to -7	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER 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:     HMCC-GI25-001_Abdelrahim_Takeda
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for FRUQUINTINIB Treatment: Refer to Section 6.4
Protocol Access Hyperlink:   HMCC-GI25-001_Abdelrahim_Takeda
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Informed Consent: Signing of the informed consent form can occur outside the 28-day screening period
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion Criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Exam: Physical exams will be performed at screening or baseline, before every cycle, EOT, the 30-day safety follow-up visit, and every two months in follow-up. A neurological exam will be conducted during each physical exam. Height and weight will be measured at screening only.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status:  ECOG will be assessed at each physical exam timepoint.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs: AEs and SAEs will be captured from the time of informed consent signing up to and including 30 days after the last treatment dose, respectively. Additionally, any SAE brought to the attention of an investigator at any time outside of the time period specified above must be reported immediately by the investigator if the event is considered to be related to the trial treatment
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications: All concomitant medications received within 28 days before the start of trial treatment and including 30 days after the last dose of trial treatment should be recorded. Concomitant medications administered 30 days after the last dose of trial treatment should be recorded for Serious Adverse Event (SAEs) and events of clinical interest (ECIs) as defined in Section 5.2.11 Assessing and Recording Adverse Events. Avoid concomitant use of fruquintinib with strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort).
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs will be performed at screening or baseline, before every cycle, EOT, the 30-day safety follow-up visit, and every two months in follow up. Vital signs include (blood pressure, oral temperature, heart rate, and respiratory rate) measurements.
			Labs
  	PT AND PTT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collection of Archived Tissue (if applicable): Tissue biopsy (optional) refers to patients' signed voluntary consent forms, and tissue archival (if applicable) at screening and when clinically indicated. A total of 11 slides will be utilized for tissue collection
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tissue Biopsy (optional)
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Tumor Assessment: Tumor assessment will be measured according to RECIST v1.1 criteria and reviewed by the investigator based on imaging (CT scan) and will be performed at screening, before cycle 3, before cycle 6, before cycle 9, before cycle 12, and at EOT
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Electrocardiography (ECG) will be performed at screening and when clinically indicated
		  	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT scan of the chest, abdomen, and pelvis with contrast will be performed at screening, before cycle 3, before cycle 6, before cycle 9, before cycle 12, and at EOT
				Day -7 to -1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER 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:     HMCC-GI25-001_Abdelrahim_Takeda
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for FRUQUINTINIB Treatment: Refer to Section 6.4
Protocol Access Hyperlink:   HMCC-GI25-001_Abdelrahim_Takeda
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: 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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs: AEs and SAEs will be captured from the time of informed consent signing up to and including 30 days after the last treatment dose, respectively. Additionally, any SAE brought to the attention of an investigator at any time outside of the time period specified above must be reported immediately by the investigator if the event is considered to be related to the trial treatment
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications: All concomitant medications received within 28 days before the start of trial treatment and including 30 days after the last dose of trial treatment should be recorded. Concomitant medications administered 30 days after the last dose of trial treatment should be recorded for Serious Adverse Event (SAEs) and events of clinical interest (ECIs) as defined in Section 5.2.11 Assessing and Recording Adverse Events. Avoid concomitant use of fruquintinib with strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort).
			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: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	CARCINOEMBRYONIC ANTIGEN (CEA)	Interval: --	Occurrences: --		  	SIGNATERA	Interval: --	Occurrences: --	Comments:	For ctDNA (optional) analyses, samples will be collected pre-treatment and post-treatment at each CEA timepoint. Since ctDNA analysis is tissue-informed, assessments will be performed after treatment has begun in order to track treatment response over time.