Adenocarcinoma of colon
Item
1. patients must have histologically or cytologically confirmed adenocarcinoma of the colon.
boolean
C0338106 (UMLS CUI [1])
Secondary malignant neoplasm of liver | Measurable lesion Quantity
Item
2. patients must have metastatic disease to the liver with at least one lesion that is measurable by recist criteria within 4 weeks prior to entry of study
boolean
C0494165 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Excision Adenocarcinoma of colon | Neoplasm Metastasis | Biopsy lesion | Adenocarcinoma of colon metastatic
Item
3. patients with a history of colon adenocarcinoma treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. clinicians should consider biopsy of lesions to establish diagnosis of metastatic colon adenocarcinoma if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
boolean
C0728940 (UMLS CUI [1,1])
C0338106 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0940828 (UMLS CUI [3])
C0338106 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
ECOG performance status
Item
4. patients must have ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Age
Item
5. patients must be >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Laboratory Results
Item
6. laboratory values <= 2 weeks prior to enrollment:
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) >= 1.5 x 10^9/l (>= 1500/mm^3)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets (plt) >= 100 x 10^9/l >= 100,000/mm^3)
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin (hgb) >= 9 g/dl
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine <= 1.5 uln
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin <= 1.5 uln
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | ERCP | Stenting Percutaneous | Liver Function Tests
Item
aspartate aminotransferase (ast/sgot) and alanine aminotransferase (alt/sgpt) <= 3.0 x uln (<= 5 x uln if liver metastases present). note: ercp or percutaneous stenting may be used to normalize the liver function tests.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0008310 (UMLS CUI [4])
C2348535 (UMLS CUI [5,1])
C0522523 (UMLS CUI [5,2])
C0023901 (UMLS CUI [6])
Protein urine absent Urine dip stick testing | Urine protein (test result) Urine dip stick testing | Creatinine clearance measurement | Urine specimen collection, 24 hours
Item
negative for proteinuria based on dip stick reading or, if documentation of +1 result for protein on dip stick reading, then total urinary protein <= 500 mg and measured creatinine clearance (crcl) >= 50 ml/min from a 24-hour urine collection
boolean
C0853155 (UMLS CUI [1,1])
C0204882 (UMLS CUI [1,2])
C1868687 (UMLS CUI [2,1])
C0204882 (UMLS CUI [2,2])
C0373595 (UMLS CUI [3])
C0455060 (UMLS CUI [4])
Life Expectancy
Item
7. life expectancy >= 12 weeks
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
8. ability to give written informed consent according to local guidelines
boolean
C0021430 (UMLS CUI [1])
Fluorouracil | Therapeutic procedure Adenocarcinoma of large intestine metastatic | Allowance Adjuvant therapy | Adenocarcinoma of large intestine Resected TNM clinical staging
Item
1. patients receiving prior 5-fu for the treatment of metastatic colorectal adenocarcinoma will be excluded from enrollment. previous use of 5-fu for adjuvant treatment of resected stage ii or iii colorectal adenocarcinoma will be allowed, provided the time from last 5-fu administration to enrollment is > 3 months.
boolean
C0016360 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1319315 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C0556660 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C1319315 (UMLS CUI [4,1])
C1521996 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
Therapeutic radiology procedure Full field Elapsed Time | Radiation Field Limited Elapsed Time | Toxicity Due to Therapeutic procedure | Patient recovered
Item
2. prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks prior to enrollment. patients must have recovered from all therapy-related toxicities. the site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
boolean
C1522449 (UMLS CUI [1,1])
C0439724 (UMLS CUI [1,2])
C2826303 (UMLS CUI [1,3])
C1882536 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C2826303 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
Biological treatment | Immunotherapy | Toxicity Due to Therapeutic procedure | Patient recovered
Item
3. prior biologic or immunotherapy <= 2 weeks prior to registration. patients must have recovered from all therapy-related toxicities
boolean
C1531518 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
Vascular Endothelial Growth Factor Inhibitors
Item
4. prior therapy with anti-vegf agents
boolean
C2267120 (UMLS CUI [1])
Cancer Other | Exception Basal cell carcinoma Inactive | Exception Squamous cell carcinoma of skin Inactive
Item
5. patients with a history of another primary malignancy <= 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0544452 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0544452 (UMLS CUI [3,3])
Investigational New Drugs
Item
6. concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment.
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding | Adult Fertility Contraceptive methods Lacking | Barrier Contraception Required | Childbearing Potential Serum pregnancy test negative
Item
7. female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. barrier contraceptives must be used throughout the trial in both sexes. women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of study treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0001675 (UMLS CUI [3,1])
C0015895 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
C0004764 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
8. patients unwilling to or unable to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])