ID

31629

Descrição

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

Palavras-chave

Versões (2)
  1. 13/09/2018 13/09/2018 -
  2. 14/09/2018 14/09/2018 -
Titular dos direitos

Virginia Commonwealth University

Transferido a

14 de setembro de 2018

DOI

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Licença

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

Inglês

Eligibility Squamous Head and Neck Cancer NCT01283178

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
candidate for chemotherapy
Descrição

Eligible for chemotherapy

Tipo de dados

boolean

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

Zubrod performance score

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

Hemoglobin > 8.0 g/dl

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

Negative pregnancy test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Descrição

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
Descrição

prior invasive malignancy except non-melanomatous skin cancers

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Prior radiation treatment to the hn region

Tipo de dados

boolean

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

Known syndromes that alter radiosensitivity

Tipo de dados

boolean

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

Medical contraindications for chemotherapy

Tipo de dados

boolean

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

Pregnant or lactating women

Tipo de dados

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
Descrição

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

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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