Eligibility Metastatic Colorectal Cancer NCT00890305

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient's age is 18 years or older, both genders.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with metastatic disease who are eligible for first line folfox chemotherapy. adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
Descripción

Neoplasm Metastasis | Eligibility First line FOLFOX Regimen | Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0392943
UMLS CUI [3,1]
C0677850
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1518409
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C1518409
3. ecog performance status ≤ 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
4. at least 4 weeks from prior major surgery or radiotherapy.
Descripción

Major surgery Previous | Prior radiation therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0279134
5. life expectancy >3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
6. hematology: anc ≥ 1.5x109/l; platelets >100x109/l.
Descripción

Hematology | Absolute neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
7. adequate renal function
Descripción

Renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
8. adequate hepatic functions
Descripción

Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
9. normal cardiac function
Descripción

Cardiac function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232164
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
Descripción

Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1518409
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C1518409
2. patients who had received oxaliplatin within 12 months prior to diagnosis of metastatic disease.
Descripción

Oxaliplatin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0069717
3. patients on concurrent anti cancer therapy other than that allowed in the study.
Descripción

Cancer treatment Illicit Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C2348563
4. patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
Descripción

Steroids | Exception Routine Antiemetics | Inhaled steroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0205547
UMLS CUI [2,3]
C0003297
UMLS CUI [3]
C2065041
5. presence of clinically apparent or suspected brain metastasis.
Descripción

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0750491
6. patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
Descripción

Myocardial Infarction | Congestive heart failure Severe | Cardiac Arrhythmia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0003811
7. serious active infection at the time of pre-study screening.
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
8. active or history of autoimmune disorders/conditions.
Descripción

Autoimmune Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004364
9. women who are pregnant or lactating
Descripción

Pregnancy | Lactation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
10. concurrent active malignancy.
Descripción

Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
11. ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
Descripción

Ascites | Pleural effusion | Osteoblastic bone metastases Disease Site Solitary

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0032227
UMLS CUI [3,1]
C3854652
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1515974
UMLS CUI [3,4]
C0205171
12. other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
Descripción

Cancer Other | Exception Malignant Neoplasms Cured | Exception Malignant Neoplasms Treated Adequate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C0205411
13. subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
Descripción

Condition Interferes with Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
14. patients with history of life threatening allergic reactions to food or drugs
Descripción

Allergic Reaction Life Threatening Food | Allergic Reaction Life Threatening Pharmaceutical Preparations

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0016452
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C0013227
15. patients with symptomatic peripheral neuropathy> grade 1.
Descripción

Peripheral Neuropathy Symptomatic CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1516728
16. known positive hiv, hepatitis b surface antigen or hepatitis c antibody.
Descripción

HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0281863

Similar models

Eligibility Metastatic Colorectal Cancer NCT00890305

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient's age is 18 years or older, both genders.
boolean
C0001779 (UMLS CUI [1])
Neoplasm Metastasis | Eligibility First line FOLFOX Regimen | Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic
Item
2. patients with metastatic disease who are eligible for first line folfox chemotherapy. adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
boolean
C0027627 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0392943 (UMLS CUI [2,3])
C0677850 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1518409 (UMLS CUI [3,3])
C0600558 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C1518409 (UMLS CUI [4,3])
ECOG performance status
Item
3. ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Major surgery Previous | Prior radiation therapy
Item
4. at least 4 weeks from prior major surgery or radiotherapy.
boolean
C0679637 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2])
Life Expectancy
Item
5. life expectancy >3 months
boolean
C0023671 (UMLS CUI [1])
Hematology | Absolute neutrophil count | Platelet Count measurement
Item
6. hematology: anc ≥ 1.5x109/l; platelets >100x109/l.
boolean
C0200627 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Renal function
Item
7. adequate renal function
boolean
C0232804 (UMLS CUI [1])
Liver function
Item
8. adequate hepatic functions
boolean
C0232741 (UMLS CUI [1])
Cardiac function
Item
9. normal cardiac function
boolean
C0232164 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic
Item
1. patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
boolean
C0677850 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1518409 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1518409 (UMLS CUI [2,3])
Oxaliplatin
Item
2. patients who had received oxaliplatin within 12 months prior to diagnosis of metastatic disease.
boolean
C0069717 (UMLS CUI [1])
Cancer treatment Illicit Study Protocol
Item
3. patients on concurrent anti cancer therapy other than that allowed in the study.
boolean
C0920425 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Steroids | Exception Routine Antiemetics | Inhaled steroids
Item
4. patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
boolean
C0038317 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0205547 (UMLS CUI [2,2])
C0003297 (UMLS CUI [2,3])
C2065041 (UMLS CUI [3])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected
Item
5. presence of clinically apparent or suspected brain metastasis.
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Myocardial Infarction | Congestive heart failure Severe | Cardiac Arrhythmia
Item
6. patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3])
Communicable Disease
Item
7. serious active infection at the time of pre-study screening.
boolean
C0009450 (UMLS CUI [1])
Autoimmune Diseases
Item
8. active or history of autoimmune disorders/conditions.
boolean
C0004364 (UMLS CUI [1])
Pregnancy | Lactation
Item
9. women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
Cancer Other
Item
10. concurrent active malignancy.
boolean
C1707251 (UMLS CUI [1])
Ascites | Pleural effusion | Osteoblastic bone metastases Disease Site Solitary
Item
11. ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
boolean
C0003962 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C3854652 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
C0205171 (UMLS CUI [3,4])
Cancer Other | Exception Malignant Neoplasms Cured | Exception Malignant Neoplasms Treated Adequate
Item
12. other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0205411 (UMLS CUI [3,4])
Condition Interferes with Protocol Compliance
Item
13. subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Allergic Reaction Life Threatening Food | Allergic Reaction Life Threatening Pharmaceutical Preparations
Item
14. patients with history of life threatening allergic reactions to food or drugs
boolean
C1527304 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Peripheral Neuropathy Symptomatic CTCAE Grades
Item
15. patients with symptomatic peripheral neuropathy> grade 1.
boolean
C0031117 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
16. known positive hiv, hepatitis b surface antigen or hepatitis c antibody.
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])