De-escalation Chemotherapies Versus Escalation in Non Pre... | NCT02842580

NCT02842580

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard arm (escalation strategy - arm A)	Active Comparator	LV5FU2 (5 FLUOROURACYL)+avastin. After progression: FOLFIRI + avastin. after the 2nd progression:FOLFOX4 (eloxatine)+ avastin.	Drug: 5 FLUOROURACYL Drug: acide folinique Drug: irinotecan Drug: Oxaliplatin Drug: capécitabine Drug: bevacizumab
Experimental arm (de-escalation strategy -arm B)	Experimental	(4 cycles of FOLFOXIRI (campto) + avastin and 4 cycles of FOLFIRI + avastin) is followed by maintenance with capecitabine	Drug: 5 FLUOROURACYL Drug: acide folinique Drug: irinotecan Drug: Oxaliplatin Drug: capécitabine Drug: bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5 FLUOROURACYL	Drug	Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). The cycles will last 14 days. For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle lasts 21 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Primary Objective Was the Percentage of Patients Without Failure of the Strategy 16 Months After the Randomization.	The failure of the strategy is defined by the following events: Progression (under certain condition) using RECIST version 1.1 and defined as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions Death (all causes) Toxicity leading to definitive stop of chemotherapy (oxaliplatine and/or irinotecan).	16 months after randomization

Secondary Outcomes

Measure	Description	Time Frame
Best Response Rate (Using RECIST Version 1.1)	Best response derived from all the CT scans performed during treatment and based on RECIST 1.1 definition of response.	At 16 months
Overall Survival (OS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastatic colorectal cancer, histologically proven (on primary tumour and/or metastases)
Unresectable and non-pretreated metastases
BRAF wild-type
Patient considered able to receive 3 lines of chemotherapy
At least one measurable target lesion > 1 cm according to RECIST 1.1 (Appendix 4)
Tumour assessment according to RECIST, performed 4 weeks or less prior to randomization
Age ≥ 18 years
WHO performance status ≤ 2 (Appendix 5)
No major surgery within 4 weeks prior to randomisation. Wound healing must be complete
Life expectancy greater than 3 months
Laboratory tests: Neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3, haemoglobin > 9 g/dL
Creatinine clearance > 30 mL /min (capecitabine dose modification if the creatinine clearance < 30-50 mL/min), serum creatinine < 1.25 x ULN
Liver function tests: bilirubin < 1.25 x ULN, AST/ALT < 5 x ULN
Women of childbearing age and men (who have sexual relations with women of childbearing age) must agree to use effective contraception without interruption throughout the duration of treatment and for 6 months after the last administration
Signed informed consent

Exclusion Criteria:

Patient with a potentially resectable colorectal cancer; i.e. for whom the goal of chemotherapy would be to make all metastases resectable
Patients with symptomatic metastases
Patient with aggressive disease and a large tumour volume
Active gastroduodenal ulcer, wound or bone fracture
At least one of the following laboratory values: Neutrophils <1500/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dL, total bilirubin > 1.5 N, alkaline phosphatase > 2.5 N (or > 5 N in case of hepatic involvement), serum creatinine > 1.5 N, 24 hr proteinuria > 1 g
Chronic inflammatory bowel disease, extensive resection of the small bowel
Clinically significant coronary artery disease or a history of myocardial infraction within the last 6 months. Uncontrolled hypertension while receiving chronic medication
Abdominal or major extra-abdominal surgical procedure (except diagnostic biopsy) or radiation within 4 weeks before starting treatment
Previous treatment with an anti-angiogenic or irinotecan
Known or suspected central nervous system metastasis CNS metastases, or suspected CNS metastases
Other previous malignancies within 5 years, except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix - Peritoneal macro-nodular carcinomatosis
History of haemoptysis ≥ grade 2 (defined as ≥ 2.5 mL of bright red blood per episode) in the month prior to inclusion
Known hypersensitivity to any component of bevacizumab or to one of the study treatments
Active infection requiring intravenous antibiotics at start of treatment
History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to treatment start
Pregnant or breastfeeding women
Concomitant participation in another clinical study involving a drug during the treatment phase and 30 days before starting the study treatment
Patient unable to undergo medical treatment for geographical, social, psychological or legal reasons.

Contacts/Locations Module

Name	Affiliation	Role
Jean Marc PHELIP, MD-PhD	CHU St Etienne	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Pierre Oudot - Service de Gastroenterologie		Bourgoin		38300	France
Ch de Cholet - Service Maladies de L4Appareil Digestif Du Dr Kaasis

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Standard Arm (Escalation Strategy - Arm A)	LV5FU2 +avastin then after progression: FOLFIRI + avastin and then after the 2nd progression:FOLFOX4 (eloxatine)+ avastin. 5 FLUOROURACYL: administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). Irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid :administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. bevacizumab: administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 6, 2016	Aug 16, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news was taken into account

Baseline population is the ITT population meaning all the patients randomized into the study

Arm/Group Information

ID	Title	Description
BG000	Standard Arm (Escalation Strategy - Arm A)	LV5FU2 +avastin then after progression: FOLFIRI + avastin and then after the 2nd progression:FOLFOX4 (eloxatine)+ avastin. 5 FLUOROURACYL: administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). Irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid :administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. bevacizumab: administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy
BG001	Experimental Arm (De-escalation Strategy -Arm B)	(4 cycles of FOLFOXIRI (campto) + avastin and 4 cycles of FOLFIRI + avastin) is followed by maintenance with capecitabine 5 FLUOROURACYL: Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). acide folinique: 200 mg/m² if Elvorine irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. capécitabine: For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle last 21 days. bevacizumab: Bevacizumab is administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00011 BG00110 BG00221

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
No strategy failure	OG0007 OG0014
Strategy failure	OG000

Secondary

Best Response Rate (Using RECIST Version 1.1)

Best response derived from all the CT scans performed during treatment and based on RECIST 1.1 definition of response.

Posted

Count of Participants

Participants

At 16 months

ID	Title	Description
OG000	Standard Arm (Escalation Strategy - Arm A)	LV5FU2 +avastin then after progression: FOLFIRI + avastin and then after the 2nd progression:FOLFOX4 (eloxatine)+ avastin. 5 FLUOROURACYL: administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). Irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid :administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. bevacizumab: administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy
OG001	Experimental Arm (De-escalation Strategy -Arm B)	(4 cycles of FOLFOXIRI (campto) + avastin and 4 cycles of FOLFIRI + avastin) is followed by maintenance with capecitabine 5 FLUOROURACYL: Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). acide folinique: 200 mg/m² if Elvorine irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. capécitabine: For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle last 21 days. bevacizumab: Bevacizumab is administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy

Secondary

Overall Survival (OS)

Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news was taken into account

Posted

Median

95% Confidence Interval

months

Up to 3 years after the treatment start

ID	Title	Description
OG000	Standard Arm (Escalation Strategy - Arm A)	LV5FU2 +avastin then after progression: FOLFIRI + avastin and then after the 2nd progression:FOLFOX4 (eloxatine)+ avastin. 5 FLUOROURACYL: administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). Irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid :administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. bevacizumab: administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy
OG001	Experimental Arm (De-escalation Strategy -Arm B)	(4 cycles of FOLFOXIRI (campto) + avastin and 4 cycles of FOLFIRI + avastin) is followed by maintenance with capecitabine 5 FLUOROURACYL: Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). acide folinique: 200 mg/m² if Elvorine irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. capécitabine: For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle last 21 days. bevacizumab: Bevacizumab is administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy

Secondary

Progression Free Survival (PFS)

The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions

Posted

Median

95% Confidence Interval

months

up to 24 months after randomization

ID	Title	Description
OG000	Standard Arm (Escalation Strategy - Arm A)	LV5FU2 +avastin then after progression: FOLFIRI + avastin and then after the 2nd progression:FOLFOX4 (eloxatine)+ avastin. 5 FLUOROURACYL: administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). Irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid :administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. bevacizumab: administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy
OG001	Experimental Arm (De-escalation Strategy -Arm B)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard Arm (Escalation Strategy - Arm A)	LV5FU2 +avastin then after progression: FOLFIRI + avastin and then after the 2nd progression:FOLFOX4 (eloxatine)+ avastin. 5 FLUOROURACYL: administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). Irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid :administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. bevacizumab: administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy	6	11	4	11	10	11
EG001	Experimental Arm (De-escalation Strategy -Arm B)	(4 cycles of FOLFOXIRI (campto) + avastin and 4 cycles of FOLFIRI + avastin) is followed by maintenance with capecitabine 5 FLUOROURACYL: Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). acide folinique: 200 mg/m² if Elvorine irinotecan: administered IV at a dose of 180 mg/m² over 90 minutes. Oxaliplatin: administered IV at a dose of 85 mg/m² over 120 minutes. capécitabine: For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle last 21 days. bevacizumab: Bevacizumab is administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy	5	10	0	10	9	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac arrest	Cardiac disorders	NCI-CTC version 4.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected10 at risk
General physical health deterioration	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected10 at risk
Hyperthermia	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected10 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected10 at risk
Fall	Injury, poisoning and procedural complications	NCI-CTC version 4.0	Systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected10 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Cardiac disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected11 at risk EG0014 affected10 at risk
Vertigo	Ear and labyrinth disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected11 at risk EG0010 affected10 at risk
Alopecia	Skin and subcutaneous tissue disorders	NCI-CTC version 4.0	Systematic Assessment	EG0004 affected11 at risk EG0012 affected10 at risk
Dry Skin	Skin and subcutaneous tissue disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected11 at risk EG0013 affected10 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	NCI-CTC version 4.0	Systematic Assessment	EG0003 affected11 at risk EG0015 affected10 at risk
Proteinuria	Renal and urinary disorders	NCI-CTC version 4.0	Systematic Assessment	EG0004 affected11 at risk EG0014 affected10 at risk
Cephalgia	Nervous system disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected11 at risk EG0012 affected10 at risk
Sensitive peripheral neuropathy	Nervous system disorders	NCI-CTC version 4.0	Systematic Assessment	EG0006 affected11 at risk EG0019 affected10 at risk
Constipation	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected11 at risk EG0013 affected10 at risk
Diarrhoea	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0008 affected11 at risk EG0017 affected10 at risk
Mucositis	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0006 affected11 at risk EG0015 affected10 at risk
Nausea	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0009 affected11 at risk EG0014 affected10 at risk
Vomiting	Gastrointestinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected11 at risk EG0013 affected10 at risk
Anxiety	Psychiatric disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected11 at risk EG0010 affected10 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	NCI-CTC version 4.0	Systematic Assessment	EG0004 affected11 at risk EG0012 affected10 at risk
Thromboembolic event	Vascular disorders	NCI-CTC version 4.0	Systematic Assessment	EG0000 affected11 at risk EG0012 affected10 at risk
Alanine aminotransferase increased	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0004 affected11 at risk EG0014 affected10 at risk
Aspartate aminotransferase increased	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected11 at risk EG0012 affected10 at risk
Anemia	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0007 affected11 at risk EG0018 affected10 at risk
Total Bilirubin increased	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected11 at risk EG0012 affected10 at risk
Gamma-glutamyltransferase increased	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0009 affected11 at risk EG0016 affected10 at risk
White blood cell count decreased	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0003 affected11 at risk EG0013 affected10 at risk
Neutrophils decreased	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected11 at risk EG0010 affected10 at risk
Phosphatases Alcalines increased	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0008 affected11 at risk EG0016 affected10 at risk
Thombopenia	Investigations	NCI-CTC version 4.0	Systematic Assessment	EG0004 affected11 at risk EG0012 affected10 at risk
Anorexia	Metabolism and nutrition disorders	NCI-CTC version 4.0	Systematic Assessment	EG0004 affected11 at risk EG0012 affected10 at risk
Hyperglycemia	Metabolism and nutrition disorders	NCI-CTC version 4.0	Systematic Assessment	EG0002 affected11 at risk EG0013 affected10 at risk
Hyperkaliemia	Metabolism and nutrition disorders	NCI-CTC version 4.0	Systematic Assessment	EG0005 affected11 at risk EG0013 affected10 at risk
Hypoalbuminumia	Metabolism and nutrition disorders	NCI-CTC version 4.0	Systematic Assessment	EG0003 affected11 at risk EG0010 affected10 at risk
Asthenia	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG0008 affected11 at risk EG0018 affected10 at risk
Fever	General disorders	NCI-CTC version 4.0	Systematic Assessment	EG0003 affected11 at risk EG0012 affected10 at risk

ID	Term
D015179	Colorectal Neoplasms
D009369	Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002955	Leucovorin
D000077146	Irinotecan
D000077150	Oxaliplatin
D000069287	Capecitabine
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003067	Coenzymes
D045762	Enzymes and Coenzymes
D002166	Camptothecin
D000470	Alkaloids
D056831	Coordination Complexes
D009930	Organic Chemicals
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins