ID

14969

Beskrivning

Metronomic Poly-chemotherapy for Metastatic CRC; ODM derived from: https://clinicaltrials.gov/show/NCT02280694

Länk

https://clinicaltrials.gov/show/NCT02280694

Nyckelord

  1. 2016-05-10 2016-05-10 -
Uppladdad den

10 maj 2016

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.

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 Colorectal Cancer NCT02280694

Eligibility Colorectal Cancer NCT02280694

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological (or cytological) proof of colorectal carcinoma (crc)
Beskrivning

Colorectal Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0009402
2. measurable metastases
Beskrivning

Neoplasm Metastasis Measurable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1513040
3. ecog (eastern cooperative oncology group) performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. progressing disease following all available chemotherapy treatment lines (including chemotherapy, bevacizumab+/-ziv-aflibercept, and an epidermal growth factor receptor (egfr) inhibitor [if wt(wild type)-kras]
Beskrivning

Progressive Neoplastic Disease | Chemotherapy Regimen | bevacizumab | ziv-aflibercept | Epidermal growth factor receptor inhibitor | KRAS wt Allele

Datatyp

boolean

Alias
UMLS CUI [1]
C0677932
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0796392
UMLS CUI [4]
C3485619
UMLS CUI [5]
C1443775
UMLS CUI [6]
C1705982
5. the central-radiologist's confirmation of pd* under the last (previous) line of "conventional treatment" and determination of pfs1, according to recist criteria
Beskrivning

Progressive Neoplastic Disease | Progression-Free Survival | Response Evaluation Criteria in Solid Tumors

Datatyp

boolean

Alias
UMLS CUI [1]
C0677932
UMLS CUI [2]
C0242792
UMLS CUI [3]
C1709926
pd (progressive disease) by recist(response evaluation criteria in solid tumors) criteria : a) there is 20% or more relative increment in the sum of diameters of target lesions in comparison with the base line sum, and their absolute increase is 5 mm. or more, or b) there appeared one or more new lesions, or c)there is substantial worsening in non-target disease
Beskrivning

Progressive Neoplastic Disease Response Evaluation Criteria in Solid Tumors | Target Lesion Identification | Increment Relative | Increase Absolute | New Lesion Identification | Non-Target Lesion Identification Worsening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677932
UMLS CUI [1,2]
C1709926
UMLS CUI [2]
C2986546
UMLS CUI [3,1]
C1705117
UMLS CUI [3,2]
C0205345
UMLS CUI [4,1]
C0442805
UMLS CUI [4,2]
C0205344
UMLS CUI [5]
C2986548
UMLS CUI [6,1]
C2986547
UMLS CUI [6,2]
C0332271
6. age: between 18 and 85
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
7. prior radiotherapy either as adjuvant treatment or for palliation is allowed, unless this was delivered to the only measurable lesion
Beskrivning

prior radiation therapy Adjuvant therapy | Palliative course of radiotherapy | Measurable lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0677850
UMLS CUI [2]
C0475092
UMLS CUI [3]
C1513041
8. complete blood counts showing normal values or any toxicity limited to grade 1.
Beskrivning

Full blood count normal | Mild Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1]
C0427692
UMLS CUI [2]
C1513302
9. blood chemistry tests showing liver and renal functions < 1.5 upper normal limit (unl)
Beskrivning

Whole Blood Chemistry Test | Liver function | Renal function | Upper Limit of Normal

Datatyp

boolean

Alias
UMLS CUI [1]
C1254486
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C1519815
10. absence of any non-hematological toxicity at grade 2 or higher
Beskrivning

Adverse Event Toxicity Grade Mild Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2697890
UMLS CUI [1,2]
C1513302
11. the experimental treatment should start within 3 to 7 weeks from the last cycle of conventional treatment
Beskrivning

Therapies, Investigational | Conventional Treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2]
C2945704
12. the patient is able to understand and ready to sign the informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. lack of confirmation of pd (under the pre-study treatment) by the central radiologist
Beskrivning

Lacking Confirmation of Progressive Neoplastic Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0521091
UMLS CUI [1,3]
C0677932
2. any concurrent other active cancer (except basal cell or squamous cell carcinoma of skin and early prostate cancer or dcis- in situ breast cancer)
Beskrivning

Malignant Neoplasms Concurrent | Basal cell carcinoma | Squamous cell carcinoma of skin | prostate cancer screening | Noninfiltrating Intraductal Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0281186
UMLS CUI [5]
C0007124
3. inability to adhere to monthly visits to the oncological unit for evaluation
Beskrivning

Unable Patient Visit Monthly

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C1512346
UMLS CUI [1,3]
C0332177
4. presence of brain metastases
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
5. continuous treatment with steroids or with nsaids or with anticoagulants during the last year (except micropirin)
Beskrivning

Therapeutic procedure | Steroids | Anti-Inflammatory Agents, Non-Steroidal | Anticoagulants | Nu-Seals Aspirin

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0038317
UMLS CUI [3]
C0003211
UMLS CUI [4]
C0003280
UMLS CUI [5]
C0591883
6. previous radiotherapy to the only site of measurable disease
Beskrivning

prior radiation therapy Measurable Disease Site

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C0205145
7. existence of active peptic ulcer or symptomatic coronary disease
Beskrivning

Peptic Ulcer | Coronary heart disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0010068
8. existence of chronic inflammatory diseases, such as ulcerative colitis or crohn's disease or rheumatoid arthritis
Beskrivning

Chronic inflammatory disorder | Ulcerative Colitis | Crohn Disease | Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C1290886
UMLS CUI [2]
C0009324
UMLS CUI [3]
C0010346
UMLS CUI [4]
C0003873
9. presence of ascites, and/or any other "third space" finding (eg. significant leg edema)
Beskrivning

Ascites | Leg edema

Datatyp

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0235886

Similar models

Eligibility Colorectal Cancer NCT02280694

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma
Item
1. histological (or cytological) proof of colorectal carcinoma (crc)
boolean
C0009402 (UMLS CUI [1])
Neoplasm Metastasis Measurable
Item
2. measurable metastases
boolean
C0027627 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
ECOG performance status
Item
3. ecog (eastern cooperative oncology group) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Progressive Neoplastic Disease | Chemotherapy Regimen | bevacizumab | ziv-aflibercept | Epidermal growth factor receptor inhibitor | KRAS wt Allele
Item
4. progressing disease following all available chemotherapy treatment lines (including chemotherapy, bevacizumab+/-ziv-aflibercept, and an epidermal growth factor receptor (egfr) inhibitor [if wt(wild type)-kras]
boolean
C0677932 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
C3485619 (UMLS CUI [4])
C1443775 (UMLS CUI [5])
C1705982 (UMLS CUI [6])
Progressive Neoplastic Disease | Progression-Free Survival | Response Evaluation Criteria in Solid Tumors
Item
5. the central-radiologist's confirmation of pd* under the last (previous) line of "conventional treatment" and determination of pfs1, according to recist criteria
boolean
C0677932 (UMLS CUI [1])
C0242792 (UMLS CUI [2])
C1709926 (UMLS CUI [3])
Progressive Neoplastic Disease Response Evaluation Criteria in Solid Tumors | Target Lesion Identification | Increment Relative | Increase Absolute | New Lesion Identification | Non-Target Lesion Identification Worsening
Item
pd (progressive disease) by recist(response evaluation criteria in solid tumors) criteria : a) there is 20% or more relative increment in the sum of diameters of target lesions in comparison with the base line sum, and their absolute increase is 5 mm. or more, or b) there appeared one or more new lesions, or c)there is substantial worsening in non-target disease
boolean
C0677932 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2])
C1705117 (UMLS CUI [3,1])
C0205345 (UMLS CUI [3,2])
C0442805 (UMLS CUI [4,1])
C0205344 (UMLS CUI [4,2])
C2986548 (UMLS CUI [5])
C2986547 (UMLS CUI [6,1])
C0332271 (UMLS CUI [6,2])
Age
Item
6. age: between 18 and 85
boolean
C0001779 (UMLS CUI [1])
prior radiation therapy Adjuvant therapy | Palliative course of radiotherapy | Measurable lesion
Item
7. prior radiotherapy either as adjuvant treatment or for palliation is allowed, unless this was delivered to the only measurable lesion
boolean
C0279134 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0475092 (UMLS CUI [2])
C1513041 (UMLS CUI [3])
Full blood count normal | Mild Adverse Event
Item
8. complete blood counts showing normal values or any toxicity limited to grade 1.
boolean
C0427692 (UMLS CUI [1])
C1513302 (UMLS CUI [2])
Whole Blood Chemistry Test | Liver function | Renal function | Upper Limit of Normal
Item
9. blood chemistry tests showing liver and renal functions < 1.5 upper normal limit (unl)
boolean
C1254486 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C1519815 (UMLS CUI [4])
Adverse Event Toxicity Grade Mild Adverse Event
Item
10. absence of any non-hematological toxicity at grade 2 or higher
boolean
C2697890 (UMLS CUI [1,1])
C1513302 (UMLS CUI [1,2])
Therapies, Investigational | Conventional Treatment
Item
11. the experimental treatment should start within 3 to 7 weeks from the last cycle of conventional treatment
boolean
C0949266 (UMLS CUI [1])
C2945704 (UMLS CUI [2])
Informed Consent
Item
12. the patient is able to understand and ready to sign the informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lacking Confirmation of Progressive Neoplastic Disease
Item
1. lack of confirmation of pd (under the pre-study treatment) by the central radiologist
boolean
C0332268 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0677932 (UMLS CUI [1,3])
Malignant Neoplasms Concurrent | Basal cell carcinoma | Squamous cell carcinoma of skin | prostate cancer screening | Noninfiltrating Intraductal Carcinoma
Item
2. any concurrent other active cancer (except basal cell or squamous cell carcinoma of skin and early prostate cancer or dcis- in situ breast cancer)
boolean
C0006826 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0281186 (UMLS CUI [4])
C0007124 (UMLS CUI [5])
Unable Patient Visit Monthly
Item
3. inability to adhere to monthly visits to the oncological unit for evaluation
boolean
C1299582 (UMLS CUI [1,1])
C1512346 (UMLS CUI [1,2])
C0332177 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain
Item
4. presence of brain metastases
boolean
C0220650 (UMLS CUI [1])
Therapeutic procedure | Steroids | Anti-Inflammatory Agents, Non-Steroidal | Anticoagulants | Nu-Seals Aspirin
Item
5. continuous treatment with steroids or with nsaids or with anticoagulants during the last year (except micropirin)
boolean
C0087111 (UMLS CUI [1])
C0038317 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C0003280 (UMLS CUI [4])
C0591883 (UMLS CUI [5])
prior radiation therapy Measurable Disease Site
Item
6. previous radiotherapy to the only site of measurable disease
boolean
C0279134 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
Peptic Ulcer | Coronary heart disease
Item
7. existence of active peptic ulcer or symptomatic coronary disease
boolean
C0030920 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
Chronic inflammatory disorder | Ulcerative Colitis | Crohn Disease | Rheumatoid Arthritis
Item
8. existence of chronic inflammatory diseases, such as ulcerative colitis or crohn's disease or rheumatoid arthritis
boolean
C1290886 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
Ascites | Leg edema
Item
9. presence of ascites, and/or any other "third space" finding (eg. significant leg edema)
boolean
C0003962 (UMLS CUI [1])
C0235886 (UMLS CUI [2])

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

Fält markerade med * är obligatoriska.

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