Colorectal Carcinoma
Item
1. histological (or cytological) proof of colorectal carcinoma (crc)
boolean
C0009402 (UMLS CUI [1])
Neoplasm Metastasis Measurable
Item
2. measurable metastases
boolean
C0027627 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
ECOG performance status
Item
3. ecog (eastern cooperative oncology group) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Progressive Neoplastic Disease | Chemotherapy Regimen | bevacizumab | ziv-aflibercept | Epidermal growth factor receptor inhibitor | KRAS wt Allele
Item
4. progressing disease following all available chemotherapy treatment lines (including chemotherapy, bevacizumab+/-ziv-aflibercept, and an epidermal growth factor receptor (egfr) inhibitor [if wt(wild type)-kras]
boolean
C0677932 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
C3485619 (UMLS CUI [4])
C1443775 (UMLS CUI [5])
C1705982 (UMLS CUI [6])
Progressive Neoplastic Disease | Progression-Free Survival | Response Evaluation Criteria in Solid Tumors
Item
5. the central-radiologist's confirmation of pd* under the last (previous) line of "conventional treatment" and determination of pfs1, according to recist criteria
boolean
C0677932 (UMLS CUI [1])
C0242792 (UMLS CUI [2])
C1709926 (UMLS CUI [3])
Progressive Neoplastic Disease Response Evaluation Criteria in Solid Tumors | Target Lesion Identification | Increment Relative | Increase Absolute | New Lesion Identification | Non-Target Lesion Identification Worsening
Item
pd (progressive disease) by recist(response evaluation criteria in solid tumors) criteria : a) there is 20% or more relative increment in the sum of diameters of target lesions in comparison with the base line sum, and their absolute increase is 5 mm. or more, or b) there appeared one or more new lesions, or c)there is substantial worsening in non-target disease
boolean
C0677932 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2])
C1705117 (UMLS CUI [3,1])
C0205345 (UMLS CUI [3,2])
C0442805 (UMLS CUI [4,1])
C0205344 (UMLS CUI [4,2])
C2986548 (UMLS CUI [5])
C2986547 (UMLS CUI [6,1])
C0332271 (UMLS CUI [6,2])
Age
Item
6. age: between 18 and 85
boolean
C0001779 (UMLS CUI [1])
prior radiation therapy Adjuvant therapy | Palliative course of radiotherapy | Measurable lesion
Item
7. prior radiotherapy either as adjuvant treatment or for palliation is allowed, unless this was delivered to the only measurable lesion
boolean
C0279134 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0475092 (UMLS CUI [2])
C1513041 (UMLS CUI [3])
Full blood count normal | Mild Adverse Event
Item
8. complete blood counts showing normal values or any toxicity limited to grade 1.
boolean
C0427692 (UMLS CUI [1])
C1513302 (UMLS CUI [2])
Whole Blood Chemistry Test | Liver function | Renal function | Upper Limit of Normal
Item
9. blood chemistry tests showing liver and renal functions < 1.5 upper normal limit (unl)
boolean
C1254486 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C1519815 (UMLS CUI [4])
Adverse Event Toxicity Grade Mild Adverse Event
Item
10. absence of any non-hematological toxicity at grade 2 or higher
boolean
C2697890 (UMLS CUI [1,1])
C1513302 (UMLS CUI [1,2])
Therapies, Investigational | Conventional Treatment
Item
11. the experimental treatment should start within 3 to 7 weeks from the last cycle of conventional treatment
boolean
C0949266 (UMLS CUI [1])
C2945704 (UMLS CUI [2])
Informed Consent
Item
12. the patient is able to understand and ready to sign the informed consent
boolean
C0021430 (UMLS CUI [1])
Lacking Confirmation of Progressive Neoplastic Disease
Item
1. lack of confirmation of pd (under the pre-study treatment) by the central radiologist
boolean
C0332268 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0677932 (UMLS CUI [1,3])
Malignant Neoplasms Concurrent | Basal cell carcinoma | Squamous cell carcinoma of skin | prostate cancer screening | Noninfiltrating Intraductal Carcinoma
Item
2. any concurrent other active cancer (except basal cell or squamous cell carcinoma of skin and early prostate cancer or dcis- in situ breast cancer)
boolean
C0006826 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0281186 (UMLS CUI [4])
C0007124 (UMLS CUI [5])
Unable Patient Visit Monthly
Item
3. inability to adhere to monthly visits to the oncological unit for evaluation
boolean
C1299582 (UMLS CUI [1,1])
C1512346 (UMLS CUI [1,2])
C0332177 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain
Item
4. presence of brain metastases
boolean
C0220650 (UMLS CUI [1])
Therapeutic procedure | Steroids | Anti-Inflammatory Agents, Non-Steroidal | Anticoagulants | Nu-Seals Aspirin
Item
5. continuous treatment with steroids or with nsaids or with anticoagulants during the last year (except micropirin)
boolean
C0087111 (UMLS CUI [1])
C0038317 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C0003280 (UMLS CUI [4])
C0591883 (UMLS CUI [5])
prior radiation therapy Measurable Disease Site
Item
6. previous radiotherapy to the only site of measurable disease
boolean
C0279134 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
Peptic Ulcer | Coronary heart disease
Item
7. existence of active peptic ulcer or symptomatic coronary disease
boolean
C0030920 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
Chronic inflammatory disorder | Ulcerative Colitis | Crohn Disease | Rheumatoid Arthritis
Item
8. existence of chronic inflammatory diseases, such as ulcerative colitis or crohn's disease or rheumatoid arthritis
boolean
C1290886 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
Ascites | Leg edema
Item
9. presence of ascites, and/or any other "third space" finding (eg. significant leg edema)
boolean
C0003962 (UMLS CUI [1])
C0235886 (UMLS CUI [2])