ID

14969

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02280694

Nyckelord

Versioner (1)
  1. 2016-05-10 2016-05-10 -
Uppladdad den

10 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT02280694

Engelsk

Eligibility Colorectal Cancer NCT02280694

1 Formulär  
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
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Similar models

Eligibility Colorectal Cancer NCT02280694

1 Formulär
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])
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