ID

30761

Beschreibung

Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00890305

Link

https://clinicaltrials.gov/show/NCT00890305

Stichworte

Versionen (1)
  1. 19.06.18 19.06.18 -
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See clinicaltrials.gov

Hochgeladen am

19. Juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00890305

Englisch

Eligibility Metastatic Colorectal Cancer NCT00890305

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

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

Major surgery Previous | Prior radiation therapy

Datentyp

boolean

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

Life Expectancy

Datentyp

boolean

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

Hematology | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

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

Renal function

Datentyp

boolean

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

Liver function

Datentyp

boolean

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

Cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic

Datentyp

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.
Beschreibung

Oxaliplatin

Datentyp

boolean

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

Cancer treatment Illicit Study Protocol

Datentyp

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
Beschreibung

Steroids | Exception Routine Antiemetics | Inhaled steroids

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Myocardial Infarction | Congestive heart failure Severe | Cardiac Arrhythmia

Datentyp

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.
Beschreibung

Communicable Disease

Datentyp

boolean

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

Autoimmune Diseases

Datentyp

boolean

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

Pregnancy | Lactation

Datentyp

boolean

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

Cancer Other

Datentyp

boolean

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

Ascites | Pleural effusion | Osteoblastic bone metastases Disease Site Solitary

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Condition Interferes with Protocol Compliance

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Peripheral Neuropathy Symptomatic CTCAE Grades

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

Eligibility Metastatic Colorectal Cancer NCT00890305

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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