Adenocarcinoma of colon metastatic Measurable | Adenocarcinoma of rectum metastatic Measurable
Item
measurable metastatic adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
systemic therapy Neoplasm Metastasis
Item
no prior systemic therapy for metastatic disease
boolean
C1515119 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Adjuvant therapy Completed | Recurrence | Therapeutic radiology procedure Completed
Item
adjuvant therapy must have been completed >/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed > 6 months prior to study entry
boolean
C0677850 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034897 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Tumor tissue Available Epidermal Growth Factor Receptor Evaluation | Tumor tissue Available Thymidine Phosphorylase Evaluation
Item
must have tumor tissue available for egfr and thymidine phosphorylase evaluation
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0475358 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0040083 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
ECOG performance status
Item
ecog ps 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age >/= 18
boolean
C0001779 (UMLS CUI [1])
Organ function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine clearance measurement
Item
adequate organ function: wbc>/=3,000, anc >/=1,500, platelets>/= 100,000, total bilirubin </= 1.5x uln, ast&alt </= 2.5x uln, create clearance >/= 50ml/min
boolean
C0678852 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and willing to sign written icf
boolean
C0021430 (UMLS CUI [1])
Able to swallow oral medication | Oral medication Absorption Ability
Item
able to swallow and absorb oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Medical condition Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Uncontrolled hypertension | Myocardial Infarction | CNS disorder | Pregnancy | Breast Feeding
Item
medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, mi w/in 6 months,cns disease, pregnancy or nursing)
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1868885 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0007682 (UMLS CUI [5])
C0032961 (UMLS CUI [6])
C0006147 (UMLS CUI [7])
Neoplasms | Skin carcinoma nonmetastatic | Carcinoma in situ of uterine cervix
Item
history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
boolean
C0027651 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1518409 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3])
Operative Surgical Procedures | Biopsy Closed | Injection/Infusion Ports Implantation | Incisional biopsy | Traumatic injury | Operative Surgical Procedures Patient need for | Fine needle aspiration biopsy | Core needle biopsy
Item
surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
boolean
C0543467 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C0677512 (UMLS CUI [2,2])
C0042371 (UMLS CUI [3,1])
C0021107 (UMLS CUI [3,2])
C0184922 (UMLS CUI [4])
C3263723 (UMLS CUI [5])
C0543467 (UMLS CUI [6,1])
C0686904 (UMLS CUI [6,2])
C1510483 (UMLS CUI [7])
C1318309 (UMLS CUI [8])
Urine protein/creatinine ratio measurement
Item
urine protein:creatinine ration >/=1.0 at screening
boolean
C1096054 (UMLS CUI [1])
Bleeding tendency Evidence of | Blood Coagulation Disorders | Anticoagulation Therapy Absent
Item
evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
boolean
C1458140 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2])
C0003281 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Infusion related reaction Severe Monoclonal Antibodies | Allergic Reaction capecitabine | Allergic Reaction oxaliplatin
Item
prior severe infusion reaction to mab or allergic reaction to capecitabine or oxaliplatin
boolean
C0948715 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0671970 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0069717 (UMLS CUI [3,2])
Neuropathy CTCAE Grades
Item
underlying neuropathy >/= grade 2
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Transient Ischemic Attack | Cerebrovascular accident
Item
tia or cva w/in 6 months
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])