0 Ratings
ID

31629

Description

Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC; ODM derived from: https://clinicaltrials.gov/show/NCT01283178 Sponsor: Virginia Commonwealth University Collaborator: National Cancer Institute (NCI) Principal Investigator: Shiyu Song Virginia Commonwealth University

Link

https://clinicaltrials.gov/show/NCT01283178

Keywords

Versions (2)
  1. 9/13/18 9/13/18 -
  2. 9/14/18 9/14/18 -
Copyright Holder

Virginia Commonwealth University

Uploaded on

September 14, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Eligibility Squamous Head and Neck Cancer NCT01283178

    English

    Eligibility Squamous Head and Neck Cancer NCT01283178

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease
    Description

    Histologic or cytologic confirmation of head and neck malignancy without evidence of metastatic disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0449575
    UMLS CUI [1,2]
    C0018671
    UMLS CUI [2]
    C1709236
    locally advanced hn scc, stages iii, iv, and bulky (> 27 cm^3 volume) stage ii, excluding larynx and nasopharynx, of no more than 150 cm^3 volume base on ct scan
    Description

    Locally advanced hn scc, stages iii, iv and bulky stage ii, exluding larynx and nasopharynx

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0677984
    UMLS CUI [1,2]
    C1168401
    UMLS CUI [1,3]
    C0332300
    UMLS CUI [1,4]
    C0023078
    UMLS CUI [1,5]
    C0027442
    UMLS CUI [1,6]
    C1300072
    UMLS CUI [1,7]
    C0475440
    all patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    candidate for chemotherapy
    Description

    Eligible for chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1548635
    UMLS CUI [1,2]
    C0392920
    zubrod performance score of 0 or 1
    Description

    Zubrod performance score

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3714786
    absolute granulocyte count (agc) >= 2000 cells/mm^3
    Description

    absolute granulocyte count (agc) >= 2000 cells/mm^3

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0857490
    platelet count >= 100,000 cells/mm^3
    Description

    platelet count >= 100,000 cells/mm^3

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    hemoglobin > 8.0 g/dl based upon cbc/differential obtained within 2 weeks prior to registration on study
    Description

    Hemoglobin > 8.0 g/dl

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019046
    serum creatinine =< 1.5 mg/dl or measured or calculated creatinine clearance >= 50 ml/min
    Description

    Serum creatinine =< 1.5 mg/dl or measured or calculated creatinine clearance >= 50 ml/min

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0017654
    negative pregnancy test within 2 weeks prior to registration for women of childbearing potential
    Description

    Negative pregnancy test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0427780
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 years
    Description

    prior invasive malignancy except non-melanomatous skin cancers

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2735087
    UMLS CUI [2,1]
    C0332300
    UMLS CUI [2,2]
    C0699893
    UMLS CUI [2,3]
    C1518408
    prior cancer treatment for this cancer, including gross total tumor excision
    Description

    Prior cancer treatment for this cancer, including gross total tumor excision

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0920425
    UMLS CUI [2,1]
    C0027651
    UMLS CUI [2,2]
    C0728940
    prior radiation treatment to the hn region
    Description

    Prior radiation treatment to the hn region

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0279134
    UMLS CUI [1,2]
    C0460004
    patients with known syndromes that alter radiosensitivity
    Description

    Known syndromes that alter radiosensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243087
    UMLS CUI [1,2]
    C4054723
    UMLS CUI [1,3]
    C0034537
    any medical contraindications for chemotherapy
    Description

    Medical contraindications for chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0392920
    pregnant or lactating women
    Description

    Pregnant or lactating women

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0022925
    women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter
    Description

    Not willing/able to use a medically acceptable form of contraception

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2,1]
    C1299582
    UMLS CUI [2,2]
    C0700589
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    Similar models

    Eligibility Squamous Head and Neck Cancer NCT01283178

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Histologic or cytologic confirmation of head and neck malignancy without evidence of metastatic disease
    Item
    histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease
    boolean
    C0449575 (UMLS CUI [1,1])
    C0018671 (UMLS CUI [1,2])
    C1709236 (UMLS CUI [2])
    Locally advanced hn scc, stages iii, iv and bulky stage ii, exluding larynx and nasopharynx
    Item
    locally advanced hn scc, stages iii, iv, and bulky (> 27 cm^3 volume) stage ii, excluding larynx and nasopharynx, of no more than 150 cm^3 volume base on ct scan
    boolean
    C0677984 (UMLS CUI [1,1])
    C1168401 (UMLS CUI [1,2])
    C0332300 (UMLS CUI [1,3])
    C0023078 (UMLS CUI [1,4])
    C0027442 (UMLS CUI [1,5])
    C1300072 (UMLS CUI [1,6])
    C0475440 (UMLS CUI [1,7])
    Informed consent
    Item
    all patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
    boolean
    C0021430 (UMLS CUI [1])
    Eligible for chemotherapy
    Item
    candidate for chemotherapy
    boolean
    C1548635 (UMLS CUI [1,1])
    C0392920 (UMLS CUI [1,2])
    Zubrod performance score
    Item
    zubrod performance score of 0 or 1
    boolean
    C3714786 (UMLS CUI [1])
    absolute granulocyte count (agc) >= 2000 cells/mm^3
    Item
    absolute granulocyte count (agc) >= 2000 cells/mm^3
    boolean
    C0857490 (UMLS CUI [1])
    platelet count >= 100,000 cells/mm^3
    Item
    platelet count >= 100,000 cells/mm^3
    boolean
    C0032181 (UMLS CUI [1])
    Hemoglobin > 8.0 g/dl
    Item
    hemoglobin > 8.0 g/dl based upon cbc/differential obtained within 2 weeks prior to registration on study
    boolean
    C0019046 (UMLS CUI [1])
    Serum creatinine =< 1.5 mg/dl or measured or calculated creatinine clearance >= 50 ml/min
    Item
    serum creatinine =< 1.5 mg/dl or measured or calculated creatinine clearance >= 50 ml/min
    boolean
    C0201976 (UMLS CUI [1])
    C0017654 (UMLS CUI [2])
    Negative pregnancy test
    Item
    negative pregnancy test within 2 weeks prior to registration for women of childbearing potential
    boolean
    C0427780 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    prior invasive malignancy except non-melanomatous skin cancers
    Item
    prior invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 years
    boolean
    C2735087 (UMLS CUI [1])
    C0332300 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    C1518408 (UMLS CUI [2,3])
    Prior cancer treatment for this cancer, including gross total tumor excision
    Item
    prior cancer treatment for this cancer, including gross total tumor excision
    boolean
    C1514463 (UMLS CUI [1,1])
    C0920425 (UMLS CUI [1,2])
    C0027651 (UMLS CUI [2,1])
    C0728940 (UMLS CUI [2,2])
    Prior radiation treatment to the hn region
    Item
    prior radiation treatment to the hn region
    boolean
    C0279134 (UMLS CUI [1,1])
    C0460004 (UMLS CUI [1,2])
    Known syndromes that alter radiosensitivity
    Item
    patients with known syndromes that alter radiosensitivity
    boolean
    C0243087 (UMLS CUI [1,1])
    C4054723 (UMLS CUI [1,2])
    C0034537 (UMLS CUI [1,3])
    Medical contraindications for chemotherapy
    Item
    any medical contraindications for chemotherapy
    boolean
    C1301624 (UMLS CUI [1,1])
    C0392920 (UMLS CUI [1,2])
    Pregnant or lactating women
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0022925 (UMLS CUI [2])
    Not willing/able to use a medically acceptable form of contraception
    Item
    women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter
    boolean
    C0558080 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
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