Colorectal Carcinoma
Item
1. histologically confirmed colorectal cancer
boolean
C0009402 (UMLS CUI [1])
Primary tumor KRAS gene Wild Type | Primary tumor NRAS gene Wild Type | Neoplasm Metastasis KRAS gene Wild Type | Neoplasm Metastasis NRAS gene Wild Type
Item
2. kras and nras wild-type genes after analysis of mutation status from the primary tumour or metastasis
boolean
C0677930 (UMLS CUI [1,1])
C1537502 (UMLS CUI [1,2])
C1883559 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C0809246 (UMLS CUI [2,2])
C1883559 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C1537502 (UMLS CUI [3,2])
C1883559 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C0809246 (UMLS CUI [4,2])
C1883559 (UMLS CUI [4,3])
Neoplasm Metastasis unresectable Curative intent
Item
3. non resectable metastatic disease in a curative intent
boolean
C0027627 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
Prior Chemotherapy Absent | Exception Fluoropyrimidine | Exception Oxaliplatin Adjuvant therapy | Oxaliplatin Adjuvant therapy Absent
Item
4. no prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment earlier than 6 months ago from randomization date
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0596581 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0069717 (UMLS CUI [3,2])
C0677850 (UMLS CUI [3,3])
C0069717 (UMLS CUI [4,1])
C0677850 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Measurable Disease Quantity | Measurable Disease Size | Therapeutic radiology procedure Absent Measurable Disease
Item
5. patient presenting with at least one measurable tumour target (greater than 20 mm) according to recist criteria, which has never been irradiated
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1513041 (UMLS CUI [3,3])
Life Expectancy
Item
6. patient with a greater than 3 month life expectancy
boolean
C0023671 (UMLS CUI [1])
Performance status
Item
7. performance status less or equal to 2
boolean
C1518965 (UMLS CUI [1])
Age
Item
8. male or female 18 years or older
boolean
C0001779 (UMLS CUI [1])
Hematologic Test Acceptable
Item
9. acceptable blood test
boolean
C0018941 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Informed Consent
Item
10. patient who has signed a written informed consent form
boolean
C0021430 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Symptomatic
Item
1. known and/or symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Hypersensitivity Therapeutic procedure Component
Item
2. known allergy to one of treatment components
boolean
C0020517 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Nervous system problem Interferes with Treatment Compliance | Mental condition Interferes with Treatment Compliance
Item
3. neurological or psychiatric condition which could interfere with good treatment compliance
boolean
C0221571 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C4319828 (UMLS CUI [2,3])
Cancer treatment | Chemotherapy | Targeted Therapy | Therapeutic radiology procedure
Item
4. patient currently in treatment with any other anti-tumour therapy: chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C2985566 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Condition Serious | Respiratory Failure | Lung Disease, Interstitial | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Chest CT scan
Item
5. other serious conditions such as: respiratory failure. history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan.
boolean
C0348080 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1145670 (UMLS CUI [2])
C0206062 (UMLS CUI [3])
C3714636 (UMLS CUI [4])
C0034069 (UMLS CUI [5])
C0206062 (UMLS CUI [6,1])
C0202823 (UMLS CUI [6,2])
Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Serious Uncontrolled
Item
6. clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrolment/randomisation
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
Communicable Disease Severe
Item
7. concomitant severe infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Skin carcinoma | Exception Malignant epithelioma of cervix In situ | Exception Curative treatment Solid Neoplasm | Exception Signs Absent Solid Neoplasm
Item
8. history of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2211895 (UMLS CUI [3,2])
C0444498 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0311392 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0280100 (UMLS CUI [5,4])
Study Subject Participation Status | Investigational New Drugs
Item
9. patient already included in another clinical trial with an investigational molecule
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Anti-EGFR Antibody | panitumumab | Vectibix | cetuximab
Item
10. prior treatment with anti-egfr antibodies (e.g. panitumumab (vectibix® or cetuximab
boolean
C4055105 (UMLS CUI [1])
C0879427 (UMLS CUI [2])
C1743549 (UMLS CUI [3])
C0995188 (UMLS CUI [4])
Erbitux | Epidermal growth factor receptor inhibitor Small Molecule | erlotinib
Item
/ erbitux® ) or treatment with small egfr inhibitor molecules (e.g., erlotinib /
boolean
C1173436 (UMLS CUI [1])
C1443775 (UMLS CUI [2,1])
C1328819 (UMLS CUI [2,2])
C1135135 (UMLS CUI [3])
Tarceva
Item
tarceva®)
boolean
C1135136 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned | Females & males of reproductive potential Contraceptive methods Absent
Item
11. pregnant female, likely to be or currently breast feeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C4034483 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Patients Deprivation Freedom | Patients Guardianship
Item
12. those deprived of their freedom or under guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0870627 (UMLS CUI [2,2])
Geographic Factors Clinical Study Follow-up Unsuccessful | Social factor Clinical Study Follow-up Unsuccessful | Mental condition Clinical Study Follow-up Unsuccessful
Item
13. impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons
boolean
C0017444 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0337460 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])