Colorectal Carcinoma unresectable TNM clinical staging | Primary tumor
Item
1. patients with histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage iv (uicc) disease (primary tumor may be present)
boolean
C0009402 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2])
Patients Appropriate FOLFOX Regimen | Adjuvant therapy Previous allowed | Palliative treatment Previous allowed
Item
2. patients who are feasible for treatment with folfox (prior adjuvant or palliative treatment is allowed)
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0392943 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0030231 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
ECOG performance status
Item
3. ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
5. age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Hematologic function
Item
6. haematologic function as follows (5% deviation allowed):
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count
Item
anc ≥ 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥ 100 x109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 9 g/dl or 5.59 mmol/l
boolean
C0518015 (UMLS CUI [1])
Liver function
Item
7. adequate liver function as follows (10% deviation allowed)
boolean
C0232741 (UMLS CUI [1])
Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
serum alanine transaminase (alt) ≤ 2.5 x uln (in case of liver metastases < 5 x uln)
boolean
C0201836 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Serum total bilirubin measurement | Gilbert Disease
Item
total bilirubin ≤ 1.5 x uln (patients with gilbert's syndrome total bilirubin
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
ID.13
Item
≤2.5 x uln)
boolean
Renal function
Item
8. adequate renal function as follows (10% deviation allowed)
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum
Item
· creatinine ≤ 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
9. signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
10. women of child-bearing potential must have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Disease Controlled | Therapeutic procedure Appropriate | Cancer treatment Systemic | Communicable Disease Uncontrolled | HIV Infection | Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis | Pregnancy | Breast Feeding | Gastrointestinal Diseases | Gastrointestinal obstruction | Malabsorption | Vomiting Uncontrolled | Diarrhea Uncontrolled | Lacking Able to swallow Oral medication | CNS metastases Symptomatic | Toxicity Due to Cancer treatment | Resolution Lacking | Operative Surgical Procedure Recovery Incomplete | Peripheral Neuropathy Oxaliplatin induced CTCAE Grades
Item
adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; 2. treatment with any systemic anticancer therapy ≤ 3 weeks prior to cycle 1 day 1 3. uncontrolled active infection (hepatitis b and c infection are not exclusion criteria) and/or known hiv infection; 4. renal failure requiring haemodialysis or peritoneal dialysis; 5. patients who are pregnant or breast-feeding; 6. patients with significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea resulting in inability to swallow oral medications; 7. presence of symptomatic cns metastasis 8. unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery, in particular oxaliplatin-induced peripheral neuropathy > grade 1.
boolean
C2911690 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
C0035078 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0019004 (UMLS CUI [6,3])
C0035078 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0031139 (UMLS CUI [7,3])
C0032961 (UMLS CUI [8])
C0006147 (UMLS CUI [9])
C0017178 (UMLS CUI [10])
C0236124 (UMLS CUI [11])
C0024523 (UMLS CUI [12])
C0042963 (UMLS CUI [13,1])
C0205318 (UMLS CUI [13,2])
C0011991 (UMLS CUI [14,1])
C0205318 (UMLS CUI [14,2])
C0332268 (UMLS CUI [15,1])
C2712086 (UMLS CUI [15,2])
C0175795 (UMLS CUI [15,3])
C0686377 (UMLS CUI [16,1])
C0231220 (UMLS CUI [16,2])
C0600688 (UMLS CUI [17,1])
C0678226 (UMLS CUI [17,2])
C0920425 (UMLS CUI [17,3])
C1514893 (UMLS CUI [18,1])
C0332268 (UMLS CUI [18,2])
C0543467 (UMLS CUI [19,1])
C2004454 (UMLS CUI [19,2])
C0205257 (UMLS CUI [19,3])
C0031117 (UMLS CUI [20,1])
C0069717 (UMLS CUI [20,2])
C0458082 (UMLS CUI [20,3])
C1516728 (UMLS CUI [20,4])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral arterial bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism
Item
9. any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0190961 (UMLS CUI [5])
C0742758 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
C0034065 (UMLS CUI [9])
C0149871 (UMLS CUI [10])
C0040038 (UMLS CUI [11])