ID

31613

Beschreibung

Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02114658 Sponsor: Bayer Information provided by (Responsible Party): Bayer

Link

https://clinicaltrials.gov/show/NCT02114658

Stichworte

Versionen (1)
  1. 12.09.18 12.09.18 -
Rechteinhaber

Bayer

Hochgeladen am

12. September 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Thyroid Carcinoma NCT02114658

Englisch

Eligibility Thyroid Carcinoma NCT02114658

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
japanese patients with atc (anaplastic thyroid carcinoma) or locally advanced or metastatic mtc (medullary thyroid carcinoma)
Beschreibung

Japanese patients with anaplastic thyroid carcinoma or locally advanced or metastatic medullary thyroid carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0238461
UMLS CUI [3,1]
C0238462
UMLS CUI [3,2]
C0677984
UMLS CUI [4,1]
C0238462
UMLS CUI [4,2]
C0036525
not a candidate for surgery or radiotherapy with curative intention
Beschreibung

ineligible for surgery or radiotherapy with curative intention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C1276305
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C1276305
histologically or cytologically confirmed atc or mtc
Beschreibung

Histologically or cytologically confirmed atc or mtc

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449575
UMLS CUI [1,2]
C0238461
UMLS CUI [2,1]
C1265900
UMLS CUI [2,2]
C0238461
UMLS CUI [3,1]
C0449575
UMLS CUI [3,2]
C0238462
UMLS CUI [4,1]
C1265900
UMLS CUI [4,2]
C0238462
measurable or non-measurable disease (but clinically evaluable) according to recist 1.1.
Beschreibung

Clinically evaluable disease according to recist 1.1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516986
UMLS CUI [1,2]
C1709926
age >= 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate bone marrow, liver and renal function to be conducted within 14 days prior to treatment
Beschreibung

adequate bone marrow, liver and renal function to be conducted within 14 days prior to treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1
Beschreibung

Ecog performance status of 0 or 1

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 weeks
Beschreibung

Life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
histologic subtypes of thyroid cancer other than anaplastic or medullary carcinoma
Beschreibung

Histologic subtypes of thyroid cancer other than anaplastic or medullary carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007115
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449560
prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target vegf or vegf (vascular endothelial growth factor) receptors or other targeted agents
Beschreibung

Prior anti-cancer targeted therapy including tyrosine kinase inhibitors, monoclonal antibodies that target vegf or vegf receptors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0879484
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C2267081
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C2917234
UMLS CUI [4,1]
C0920425
UMLS CUI [4,2]
C2985566
prior chemotherapy for thyroid cancer (only one regimen is allowed)
Beschreibung

Prior chemotherapy for thyroid cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007115
major surgery, open biopsy, or significant traumatic injury within 30 days prior to enrollment in the study.
Beschreibung

Major surgery, open biopsy or significant traumatic injury within 30 days prior to enrollment in the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0679637
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0184922
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C3263723
subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding but without having received local treatment prior to enrollment in the study
Beschreibung

Subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332448
UMLS CUI [1,2]
C0040578
UMLS CUI [1,3]
C3251812
UMLS CUI [2,1]
C0332448
UMLS CUI [2,2]
C0006255
UMLS CUI [2,3]
C3251812
UMLS CUI [3,1]
C0332448
UMLS CUI [3,2]
C0014876
UMLS CUI [3,3]
C3251812
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Ähnliche Modelle

Eligibility Thyroid Carcinoma NCT02114658

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Japanese patients with anaplastic thyroid carcinoma or locally advanced or metastatic medullary thyroid carcinoma
Item
japanese patients with atc (anaplastic thyroid carcinoma) or locally advanced or metastatic mtc (medullary thyroid carcinoma)
boolean
C1556094 (UMLS CUI [1])
C0238461 (UMLS CUI [2])
C0238462 (UMLS CUI [3,1])
C0677984 (UMLS CUI [3,2])
C0238462 (UMLS CUI [4,1])
C0036525 (UMLS CUI [4,2])
ineligible for surgery or radiotherapy with curative intention
Item
not a candidate for surgery or radiotherapy with curative intention
boolean
C1512714 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
C1512714 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1276305 (UMLS CUI [2,3])
Histologically or cytologically confirmed atc or mtc
Item
histologically or cytologically confirmed atc or mtc
boolean
C0449575 (UMLS CUI [1,1])
C0238461 (UMLS CUI [1,2])
C1265900 (UMLS CUI [2,1])
C0238461 (UMLS CUI [2,2])
C0449575 (UMLS CUI [3,1])
C0238462 (UMLS CUI [3,2])
C1265900 (UMLS CUI [4,1])
C0238462 (UMLS CUI [4,2])
Clinically evaluable disease according to recist 1.1
Item
measurable or non-measurable disease (but clinically evaluable) according to recist 1.1.
boolean
C1516986 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
adequate bone marrow, liver and renal function to be conducted within 14 days prior to treatment
Item
adequate bone marrow, liver and renal function to be conducted within 14 days prior to treatment
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Ecog performance status of 0 or 1
Item
eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Histologic subtypes of thyroid cancer other than anaplastic or medullary carcinoma
Item
histologic subtypes of thyroid cancer other than anaplastic or medullary carcinoma
boolean
C0007115 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449560 (UMLS CUI [1,3])
Prior anti-cancer targeted therapy including tyrosine kinase inhibitors, monoclonal antibodies that target vegf or vegf receptors
Item
prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target vegf or vegf (vascular endothelial growth factor) receptors or other targeted agents
boolean
C0920425 (UMLS CUI [1,1])
C0879484 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C2267081 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3,1])
C2917234 (UMLS CUI [3,2])
C0920425 (UMLS CUI [4,1])
C2985566 (UMLS CUI [4,2])
Prior chemotherapy for thyroid cancer
Item
prior chemotherapy for thyroid cancer (only one regimen is allowed)
boolean
C1514457 (UMLS CUI [1,1])
C0007115 (UMLS CUI [1,2])
Major surgery, open biopsy or significant traumatic injury within 30 days prior to enrollment in the study
Item
major surgery, open biopsy, or significant traumatic injury within 30 days prior to enrollment in the study.
boolean
C0332185 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0184922 (UMLS CUI [2,2])
C0332185 (UMLS CUI [3,1])
C3263723 (UMLS CUI [3,2])
Subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding
Item
subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding but without having received local treatment prior to enrollment in the study
boolean
C0332448 (UMLS CUI [1,1])
C0040578 (UMLS CUI [1,2])
C3251812 (UMLS CUI [1,3])
C0332448 (UMLS CUI [2,1])
C0006255 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])
C0332448 (UMLS CUI [3,1])
C0014876 (UMLS CUI [3,2])
C3251812 (UMLS CUI [3,3])
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