Adenocarcinoma of large intestine unresectable | Carcinoma of the Appendix Excluded | Carcinoma of anal canal Excluded
Item
1. patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
boolean
C1319315 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0728951 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0563211 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Measurable lesion
Item
2. patients with measurable lesion(s) according to the recist ver. 1.1
boolean
C1513041 (UMLS CUI [1])
Chemotherapy Absent Colorectal Carcinoma | Recurrent disease | Status post Adjuvant Chemotherapy perioperative | fluoropyrimidine
Item
3. patients who have not received chemotherapy for colorectal cancer. patients who experience relapse more than 6 months after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0085533 (UMLS CUI [3,2])
C1518988 (UMLS CUI [3,3])
C0596581 (UMLS CUI [4])
Age
Item
4. aged ≥ 20 years at the time of informed consent
boolean
C0001779 (UMLS CUI [1])
Patients KRAS Wild Type | Patients NRAS Wild Type
Item
5. patients classified as kras wild-type. however, the criteria will be changed to all patients who are verified to be of kras and nras wild-type when the kras and nras tests come to be covered by national health insurance, and the tests become feasible at medical institutions.
boolean
C0030705 (UMLS CUI [1,1])
C1537502 (UMLS CUI [1,2])
C1883559 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0809246 (UMLS CUI [2,2])
C1883559 (UMLS CUI [2,3])
Organ Major function | Neutrophil count | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
6. patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment 1) neutrophil count ≥ 1.5 × 103/μl 2) white blood cell count ≥ 3.0 × 103/μl 3) platelet count ≥ 10.0 × 104/μl 4) hemoglobin
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0200633 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Alanine aminotransferase measurement | Creatinine measurement, serum
Item
≥ 9.0 g/dl 5) total bilirubin ≤ 2.0 mg/dl 6) ast ≤ 100 u/l (≤ 200 u/l if liver metastases are present) 7) alt ≤ 100 u/l (≤ 200 u/l if liver metastases are present) 8) serum creatinine ≤ 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
ECOG performance status
Item
7. patients who are assessed at eastern cooperative oncology group (ecog) performance status (p.s.) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
8. life expectancy of ≥ 6 months after enrollment
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
9. patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
boolean
C0021430 (UMLS CUI [1])
Inclusion criteria Randomization
Item
inclusion criteria for randomization:
boolean
C1512693 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Combined Modality Therapy Course Quantity | FOLFOX-6 Regimen modified | panitumumab
Item
1. patients who have received 6 cycles of mfolfox6 + panitumumab combination therapy
boolean
C0009429 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1880660 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0879427 (UMLS CUI [3])
ECOG performance status
Item
2. patients who are assessed at ecog p.s. of 0-1 in the 6th cycle.
boolean
C1520224 (UMLS CUI [1])
Progressive Disease Absent Diagnostic Imaging | Evaluable Disease Diagnostic Imaging
Item
3. patients for whom pd or not evaluable has been denied on the recist based on imaging tests conducted after the day of administration in the 6th cycle within 14 days (2 weeks).
boolean
C1335499 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C1516986 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Exclusion Criteria Enrollment
Item
exclusion criteria for enrollment:
boolean
C0680251 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Therapeutic radiology procedure Measurable lesion
Item
1. radiotherapy received for a measurable lesion
boolean
C1522449 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
Therapeutic radiology procedure Lesion | Exception Measurable lesion
Item
2. radiotherapy received within 28 days (4 weeks) prior to enrollment for a lesion other than measurable lesions
boolean
C1522449 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Strong Suspected
Item
3. known brain metastasis or strongly suspected of brain metastasis
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Malignant Neoplasms Synchronous | Metachronous Malignant Neoplasm | Period Disease Free | Exception Colorectal Carcinoma | Exception Malignant Neoplasm Mucous Membrane Cured | Exception Malignant Neoplasm Mucous Membrane Resected | Exception Esophageal carcinoma | Exception Stomach Carcinoma | Exception Cervical cancer | Exception Skin carcinoma | Exception Carcinoma of bladder
Item
4. synchronous cancers or metachronous cancers with a disease-free period of ≤ 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).
boolean
C0006826 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C1334703 (UMLS CUI [2])
C1948053 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0009402 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0026724 (UMLS CUI [5,3])
C1880198 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0026724 (UMLS CUI [6,3])
C1521996 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0152018 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0699791 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C4048328 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0699893 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0699885 (UMLS CUI [11,2])
Body cavity fluid Treatment required for | Pleural effusion | Ascites | Pericardial effusion
Item
5. body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
boolean
C0333343 (UMLS CUI [1,1])
C0005889 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C1253943 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0031039 (UMLS CUI [4])
Contraceptive methods Unwilling | Pregnancy | Breast Feeding | Pregnancy test positive
Item
6. patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Hemorrhage Requirement Blood Transfusion
Item
7. active hemorrhage requiring blood transfusion
boolean
C0019080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0005841 (UMLS CUI [1,3])
Disease Requirement Systemic steroids | Topical steroids Excluded
Item
8. disease requiring systemic steroids for treatment (excluding topical steroids)
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C2064827 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Intestinal resection | Colostomy
Item
9. intestinal resection and colostomy within 2 weeks prior to enrollment
boolean
C1096244 (UMLS CUI [1])
C0009410 (UMLS CUI [2])
Lung Disease, Interstitial | Interstitial Lung Disease CT | Pneumonia, Interstitial | Pulmonary Fibrosis
Item
10. history or obvious and extensive ct findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
boolean
C0206062 (UMLS CUI [1])
C0206062 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0206061 (UMLS CUI [3])
C0034069 (UMLS CUI [4])
Drug Allergy Serious
Item
11. serious drug hypersensitivity
boolean
C0013182 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Local infection Treatment required for | Sepsis Treatment required for | Fever | Communicable Disease Indicated
Item
12. local or systemic active infection requiring treatment, or fever indicating infection
boolean
C1400591 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0015967 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C1444656 (UMLS CUI [4,2])
Paralytic Ileus | Gastrointestinal obstruction | Diarrhea Uncontrolled
Item
13. intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhea (incapacitating symptoms despite adequate treatment)
boolean
C0030446 (UMLS CUI [1])
C0236124 (UMLS CUI [2])
C0011991 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Hepatitis B | Hepatitis C
Item
14. active hepatitis b and/or active hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection
Item
15. known human immunodeficiency virus infection
boolean
C0019693 (UMLS CUI [1])
Study Subject Participation Status Ineligible
Item
16. other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Exclusion Criteria Randomization
Item
exclusion criteria for randomization:
boolean
C0680251 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Pneumonia, Interstitial
Item
1. patients in whom interstitial pneumonia has been newly diagnosed during the period from registration to randomization
boolean
C0206061 (UMLS CUI [1])
Therapeutic radiology procedure
Item
2. patients who have received radiotherapy during the period from registration to randomization
boolean
C1522449 (UMLS CUI [1])
Study Subject Participation Status Ineligible
Item
3. other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])