Adenocarcinoma of large intestine metastatic
Item
1. histologically or cytologically confirmed diagnosis of metastatic colorectal adenocarcinoma
boolean
C1319315 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
Absence Prior Chemotherapy Neoplasm Metastasis
Item
2. no prior chemotherapy for metastatic disease
boolean
C0332197 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Age
Item
3. age ≥18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Life Expectancy
Item
4. eastern cooperative oncology group (ecog) performance status ≤ 2 (5. life expectancy > 3 months
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Organ function | Bone Marrow function | Absolute neutrophil count
Item
5. adequate organ function, including bone marrow (absolute neutrophil count (anc)
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0948762 (UMLS CUI [3])
Hemoglobin measurement | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver | Renal function | Creatinine measurement, serum
Item
≥l500/μl, haemoglobin ≥ 9g/dl, platelets ≥ 100,000/ μl); hepatic (total bilirubin < 1.6 mg/dl;sgot and sgpt < 2.5 x upper limit of normal for patients without liver metastases and < 5x upper limit of normal for patients with liver metastases); and renal (serum creatinine ≤ 1.5x upper limit of normal).
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0494165 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0494165 (UMLS CUI [8])
C0232804 (UMLS CUI [9])
C0201976 (UMLS CUI [10])
UGT1A1*28 Allele Genotype determination | UGT1A1 gene allele 1 Genotype determination
Item
6. patients who are eligible to be registered in the study, based upon the above criteria, will be genotyped for the ugt1a1*28 polymorphism and stratified into two groups based on the presence of the ugt1a1*1/*1 or ugt1a1*1/*28 genotype.
boolean
C2825127 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C2360711 (UMLS CUI [2,1])
C1285573 (UMLS CUI [2,2])
UGT1A1*28 allele carrier Excluded | Other Coding
Item
7. patients with the ugt1a1*28/*28 genotype or carriers of the other alleles (ta5 and ta8)will be excluded.
boolean
C3888950 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Evaluable Patient Secondary Endpoint | Measurable Disease Quantity | Measurable Disease Dimension Quantity | Longest Diameter Technique conventional | Longest Diameter Spiral CT scan
Item
8. for patients to be evaluable for response (a secondary end point), they must have at least one measurable lesion as defined by recist (i.e., lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral ct scan).
boolean
C2986511 (UMLS CUI [1,1])
C4528314 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0552406 (UMLS CUI [4,1])
C0449851 (UMLS CUI [4,2])
C0439858 (UMLS CUI [4,3])
C0552406 (UMLS CUI [5,1])
C0860888 (UMLS CUI [5,2])
Measurable Disease Absent | Evaluation Toxicity
Item
9. patients without measurable lesions can be included and will be evaluated only for toxicity.
boolean
C1513041 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
Informed Consent
Item
10. signed informed consent and local irb approval is required.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
11. women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, up until 30 days after final study treatment. should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
irinotecan | bevacizumab
Item
1. prior irinotecan or bevacizumab treatment
boolean
C0123931 (UMLS CUI [1])
C0796392 (UMLS CUI [2])
Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis
Item
2. inflammatory bowel disease (crohn's disease, ulcerative colitis)
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
Diarrhea CTCAE Grades
Item
3. diarrhea greater than grade 1
boolean
C0011991 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Intestinal Obstruction
Item
4. bowel obstruction
boolean
C0021843 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
5. documented brain metastases
boolean
C0220650 (UMLS CUI [1])
Communicable Disease Serious
Item
6. serious active infectious disease
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Bleeding uncontrolled | Fistula Uncontrolled
Item
7. active uncontrolled bleeding or fistulas
boolean
C3842135 (UMLS CUI [1])
C0016169 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Pregnancy
Item
8. pregnancy
boolean
C0032961 (UMLS CUI [1])
Therapeutic radiology procedure | Major surgery
Item
9. radiotherapy or major surgery within 4 weeks
boolean
C1522449 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Disease Free of
Item
10. previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been disease-free for five years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])