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ID

14969

Description

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

Link

https://clinicaltrials.gov/show/NCT02280694

Keywords

Versions (1)
  1. 5/10/16 5/10/16 -
Uploaded on

May 10, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Colorectal Cancer NCT02280694

    English

    Eligibility Colorectal Cancer NCT02280694

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    Colorectal Carcinoma

    Data type

    boolean

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

    Neoplasm Metastasis Measurable

    Data type

    boolean

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

    ECOG performance status

    Data type

    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]
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

    Age

    Data type

    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
    Description

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

    Data type

    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.
    Description

    Full blood count normal | Mild Adverse Event

    Data type

    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)
    Description

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

    Data type

    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
    Description

    Adverse Event Toxicity Grade Mild Adverse Event

    Data type

    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
    Description

    Therapies, Investigational | Conventional Treatment

    Data type

    boolean

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

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    Lacking Confirmation of Progressive Neoplastic Disease

    Data type

    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)
    Description

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

    Data type

    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
    Description

    Unable Patient Visit Monthly

    Data type

    boolean

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

    Metastatic malignant neoplasm to brain

    Data type

    boolean

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

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

    Data type

    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
    Description

    prior radiation therapy Measurable Disease Site

    Data type

    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
    Description

    Peptic Ulcer | Coronary heart disease

    Data type

    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
    Description

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

    Data type

    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)
    Description

    Ascites | Leg edema

    Data type

    boolean

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

    Eligibility Colorectal Cancer NCT02280694

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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