Prior Chemotherapy Absent Advanced disease | Prior Chemotherapy Absent Neoplasm Metastasis | Chemotherapy, Adjuvant | Chemoradiotherapy, Adjuvant
Item
1. patient must not have had prior chemotherapy for advanced or metastatic disease. patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0085533 (UMLS CUI [3])
C3178761 (UMLS CUI [4])
Colorectal cancer metastatic | Indication Chemotherapy Combined Biological treatment
Item
2. patient with mcrc for whom bio-chemotherapy is indicated.
boolean
C0948380 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0205195 (UMLS CUI [2,3])
C1531518 (UMLS CUI [2,4])
Measurable Disease Site Quantity | Therapeutic radiology procedure Absent Measurable Disease | Prior radiation therapy Lesion | Disease Progression
Item
3. patients must have at least one measurable non-irradiated site of disease according to recist (version 1.1) criteria. if the patient has had previous irradiation of the marker lesion(s), there must be evidence of progression since the radiation.
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
Major surgery | Therapeutic radiology procedure Completed | Cancer treatment Systemic Completed
Item
4. minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
ECOG performance status
Item
5. ecog performance status ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function
Item
6. adequate bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Liver function | Parameters Specific
Item
7. adequate liver function defined within specific parameters
boolean
C0232741 (UMLS CUI [1])
C0449381 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Renal function | Parameters Specific
Item
8. adequate renal function defined within specific parameters
boolean
C0232804 (UMLS CUI [1])
C0449381 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Coagulation Parameters | Parameters Specific
Item
9. adequate coagulation parameters defined within specific parameters
boolean
C0005778 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0449381 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative
Item
10. negative pregnancy test for females of a childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Partner in relationship Contraceptive methods
Item
11. use of an effective form of contraception during the study (for subjects of childbearing potential and their partners).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Life Expectancy
Item
12. life expectation ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Prior Therapy Colorectal Carcinoma Advanced | Prior Therapy Colorectal cancer metastatic
Item
1. prior treatment for advanced or metastatic colorectal cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0948380 (UMLS CUI [2,2])
Angiogenesis Inhibitors Neoadjuvant Therapy | Angiogenesis Inhibitors Adjuvant therapy
Item
2. prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting.
boolean
C0596087 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0596087 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
Antineoplastic Agents Investigational
Item
3. concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment).
boolean
C0003392 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Cancer Other | Exception In complete remission | Exception Cancer treatment Completed
Item
4. history of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Systemic steroids chronic | Immunosuppressive Agents chronic | Topical form corticosteroids allowed | Adrenal Cortex Hormones Inhaled allowed
Item
5. chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed.
boolean
C2825233 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0304604 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C0001559 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Immunization Attenuated Vaccines Scheduled
Item
6. scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry.
boolean
C0020971 (UMLS CUI [1,1])
C0042211 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Uncontrolled | Metastatic Malignant Neoplasm to the Leptomeninges Uncontrolled | Glucocorticoids Required Metastatic malignant neoplasm to brain | Glucocorticoids Required Metastatic Malignant Neoplasm to the Leptomeninges
Item
7. uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or lepto-meningeal metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0220650 (UMLS CUI [3,3])
C0017710 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C1704231 (UMLS CUI [4,3])
Hemorrhage | Bleeding tendency | Vitamin K antagonists | Exception Coumadin Low dose | Blood Coagulation Disorders
Item
8. patients with active bleeding or history of bleeding diathesis on oral anti-vitamin k medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C3653316 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0699129 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
C0005779 (UMLS CUI [5])
Cerebrovascular accident | Transient Ischemic Attack | Subarachnoid Hemorrhage
Item
9. patients with history of cerebral vascular accident, transient ischemic attack, or subarachnoid haemorrhage within the past 6 month prior to randomization.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0038525 (UMLS CUI [3])
Medical condition Severe Affecting Study Subject Participation Status | Medical condition Uncontrolled Affecting Study Subject Participation Status
Item
10. patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Non-healed wound Serious | Ulcer | Bone fracture | Major surgery | Traumatic injury
Item
11. patients with serious non-healing wound, ulcer, bone fracture, or with a major surgical procedure, or significant traumatic injury within 4 weeks prior to randomization
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
C0679637 (UMLS CUI [4])
C3263723 (UMLS CUI [5])
Sign or Symptom Gastrointestinal obstruction | Requirement Hydration Therapy Parenteral | Requirement Parenteral Nutrition | Requirement Parenteral nutrition and hydration
Item
12. patients with clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition.
boolean
C3540840 (UMLS CUI [1,1])
C0236124 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1881074 (UMLS CUI [2,2])
C1518896 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0030547 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C2223918 (UMLS CUI [4,2])
Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
13. patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization.
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Ingredient
Item
14. patients with history of hypersensitivity to any of the study drugs or ingredients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])