ID

36401

Beskrivning

Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients With RAS Wild-type Metastatic Colorectal Cancer); ODM derived from: https://clinicaltrials.gov/show/NCT02404935

Länk

https://clinicaltrials.gov/show/NCT02404935

Nyckelord

Versioner (1)
  1. 2019-05-10 2019-05-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 maj 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Metastatic Colorectal Cancer NCT02404935

Engelsk

Eligibility Metastatic Colorectal Cancer NCT02404935

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed colorectal cancer
Beskrivning

Colorectal Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0009402
2. kras and nras wild-type genes after analysis of mutation status from the primary tumour or metastasis
Beskrivning

Primary tumor KRAS gene Wild Type | Primary tumor NRAS gene Wild Type | Neoplasm Metastasis KRAS gene Wild Type | Neoplasm Metastasis NRAS gene Wild Type

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1537502
UMLS CUI [1,3]
C1883559
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0809246
UMLS CUI [2,3]
C1883559
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1537502
UMLS CUI [3,3]
C1883559
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0809246
UMLS CUI [4,3]
C1883559
3. non resectable metastatic disease in a curative intent
Beskrivning

Neoplasm Metastasis unresectable Curative intent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C1276305
4. no prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment earlier than 6 months ago from randomization date
Beskrivning

Prior Chemotherapy Absent | Exception Fluoropyrimidine | Exception Oxaliplatin Adjuvant therapy | Oxaliplatin Adjuvant therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0596581
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0069717
UMLS CUI [3,3]
C0677850
UMLS CUI [4,1]
C0069717
UMLS CUI [4,2]
C0677850
UMLS CUI [4,3]
C0332197
5. patient presenting with at least one measurable tumour target (greater than 20 mm) according to recist criteria, which has never been irradiated
Beskrivning

Measurable Disease Quantity | Measurable Disease Size | Therapeutic radiology procedure Absent Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0456389
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C1513041
6. patient with a greater than 3 month life expectancy
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
7. performance status less or equal to 2
Beskrivning

Performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
8. male or female 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
9. acceptable blood test
Beskrivning

Hematologic Test Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1879533
10. patient who has signed a written informed consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known and/or symptomatic brain metastases
Beskrivning

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
2. known allergy to one of treatment components
Beskrivning

Hypersensitivity Therapeutic procedure Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1705248
3. neurological or psychiatric condition which could interfere with good treatment compliance
Beskrivning

Nervous system problem Interferes with Treatment Compliance | Mental condition Interferes with Treatment Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221571
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C4319828
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C4319828
4. patient currently in treatment with any other anti-tumour therapy: chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
Beskrivning

Cancer treatment | Chemotherapy | Targeted Therapy | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0392920
UMLS CUI [3]
C2985566
UMLS CUI [4]
C1522449
5. other serious conditions such as: respiratory failure. history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan.
Beskrivning

Condition Serious | Respiratory Failure | Lung Disease, Interstitial | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Chest CT scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C1145670
UMLS CUI [3]
C0206062
UMLS CUI [4]
C3714636
UMLS CUI [5]
C0034069
UMLS CUI [6,1]
C0206062
UMLS CUI [6,2]
C0202823
6. clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrolment/randomisation
Beskrivning

Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0742758
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0205318
7. concomitant severe infection.
Beskrivning

Communicable Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
8. history of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
Beskrivning

Malignant Neoplasms | Exception Skin carcinoma | Exception Malignant epithelioma of cervix In situ | Exception Curative treatment Solid Neoplasm | Exception Signs Absent Solid Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2211895
UMLS CUI [3,3]
C0444498
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0280100
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0311392
UMLS CUI [5,3]
C0332197
UMLS CUI [5,4]
C0280100
9. patient already included in another clinical trial with an investigational molecule
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
10. prior treatment with anti-egfr antibodies (e.g. panitumumab (vectibix® or cetuximab
Beskrivning

Anti-EGFR Antibody | panitumumab | Vectibix | cetuximab

Datatyp

boolean

Alias
UMLS CUI [1]
C4055105
UMLS CUI [2]
C0879427
UMLS CUI [3]
C1743549
UMLS CUI [4]
C0995188
/ erbitux® ) or treatment with small egfr inhibitor molecules (e.g., erlotinib /
Beskrivning

Erbitux | Epidermal growth factor receptor inhibitor Small Molecule | erlotinib

Datatyp

boolean

Alias
UMLS CUI [1]
C1173436
UMLS CUI [2,1]
C1443775
UMLS CUI [2,2]
C1328819
UMLS CUI [3]
C1135135
tarceva®)
Beskrivning

Tarceva

Datatyp

boolean

Alias
UMLS CUI [1]
C1135136
11. pregnant female, likely to be or currently breast feeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned | Females & males of reproductive potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
12. those deprived of their freedom or under guardianship
Beskrivning

Patients Deprivation Freedom | Patients Guardianship

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0870627
13. impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons
Beskrivning

Geographic Factors Clinical Study Follow-up Unsuccessful | Social factor Clinical Study Follow-up Unsuccessful | Mental condition Clinical Study Follow-up Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017444
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0337460
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C1272705
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C1272705
Tillbaka till toppen

Similar models

Eligibility Metastatic Colorectal Cancer NCT02404935

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma
Item
1. histologically confirmed colorectal cancer
boolean
C0009402 (UMLS CUI [1])
Primary tumor KRAS gene Wild Type | Primary tumor NRAS gene Wild Type | Neoplasm Metastasis KRAS gene Wild Type | Neoplasm Metastasis NRAS gene Wild Type
Item
2. kras and nras wild-type genes after analysis of mutation status from the primary tumour or metastasis
boolean
C0677930 (UMLS CUI [1,1])
C1537502 (UMLS CUI [1,2])
C1883559 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C0809246 (UMLS CUI [2,2])
C1883559 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C1537502 (UMLS CUI [3,2])
C1883559 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C0809246 (UMLS CUI [4,2])
C1883559 (UMLS CUI [4,3])
Neoplasm Metastasis unresectable Curative intent
Item
3. non resectable metastatic disease in a curative intent
boolean
C0027627 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
Prior Chemotherapy Absent | Exception Fluoropyrimidine | Exception Oxaliplatin Adjuvant therapy | Oxaliplatin Adjuvant therapy Absent
Item
4. no prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment earlier than 6 months ago from randomization date
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0596581 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0069717 (UMLS CUI [3,2])
C0677850 (UMLS CUI [3,3])
C0069717 (UMLS CUI [4,1])
C0677850 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Measurable Disease Quantity | Measurable Disease Size | Therapeutic radiology procedure Absent Measurable Disease
Item
5. patient presenting with at least one measurable tumour target (greater than 20 mm) according to recist criteria, which has never been irradiated
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1513041 (UMLS CUI [3,3])
Life Expectancy
Item
6. patient with a greater than 3 month life expectancy
boolean
C0023671 (UMLS CUI [1])
Performance status
Item
7. performance status less or equal to 2
boolean
C1518965 (UMLS CUI [1])
Age
Item
8. male or female 18 years or older
boolean
C0001779 (UMLS CUI [1])
Hematologic Test Acceptable
Item
9. acceptable blood test
boolean
C0018941 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Informed Consent
Item
10. patient who has signed a written informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Symptomatic
Item
1. known and/or symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Hypersensitivity Therapeutic procedure Component
Item
2. known allergy to one of treatment components
boolean
C0020517 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Nervous system problem Interferes with Treatment Compliance | Mental condition Interferes with Treatment Compliance
Item
3. neurological or psychiatric condition which could interfere with good treatment compliance
boolean
C0221571 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C4319828 (UMLS CUI [2,3])
Cancer treatment | Chemotherapy | Targeted Therapy | Therapeutic radiology procedure
Item
4. patient currently in treatment with any other anti-tumour therapy: chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C2985566 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Condition Serious | Respiratory Failure | Lung Disease, Interstitial | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Chest CT scan
Item
5. other serious conditions such as: respiratory failure. history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan.
boolean
C0348080 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1145670 (UMLS CUI [2])
C0206062 (UMLS CUI [3])
C3714636 (UMLS CUI [4])
C0034069 (UMLS CUI [5])
C0206062 (UMLS CUI [6,1])
C0202823 (UMLS CUI [6,2])
Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Serious Uncontrolled
Item
6. clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrolment/randomisation
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
Communicable Disease Severe
Item
7. concomitant severe infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Skin carcinoma | Exception Malignant epithelioma of cervix In situ | Exception Curative treatment Solid Neoplasm | Exception Signs Absent Solid Neoplasm
Item
8. history of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2211895 (UMLS CUI [3,2])
C0444498 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0311392 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0280100 (UMLS CUI [5,4])
Study Subject Participation Status | Investigational New Drugs
Item
9. patient already included in another clinical trial with an investigational molecule
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Anti-EGFR Antibody | panitumumab | Vectibix | cetuximab
Item
10. prior treatment with anti-egfr antibodies (e.g. panitumumab (vectibix® or cetuximab
boolean
C4055105 (UMLS CUI [1])
C0879427 (UMLS CUI [2])
C1743549 (UMLS CUI [3])
C0995188 (UMLS CUI [4])
Erbitux | Epidermal growth factor receptor inhibitor Small Molecule | erlotinib
Item
/ erbitux® ) or treatment with small egfr inhibitor molecules (e.g., erlotinib /
boolean
C1173436 (UMLS CUI [1])
C1443775 (UMLS CUI [2,1])
C1328819 (UMLS CUI [2,2])
C1135135 (UMLS CUI [3])
Tarceva
Item
tarceva®)
boolean
C1135136 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned | Females & males of reproductive potential Contraceptive methods Absent
Item
11. pregnant female, likely to be or currently breast feeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C4034483 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Patients Deprivation Freedom | Patients Guardianship
Item
12. those deprived of their freedom or under guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0870627 (UMLS CUI [2,2])
Geographic Factors Clinical Study Follow-up Unsuccessful | Social factor Clinical Study Follow-up Unsuccessful | Mental condition Clinical Study Follow-up Unsuccessful
Item
13. impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons
boolean
C0017444 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0337460 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial