ID

42480

Descrição

Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3); ODM derived from: https://clinicaltrials.gov/show/NCT02248012

Link

https://clinicaltrials.gov/show/NCT02248012

Palavras-chave

Versões (1)
  1. 17/07/2021 17/07/2021 -
Titular dos direitos

Haukeland University Hospital Skane University Hospital Copenhagen University Hospital, Denmark Rigshospitalet, Denmark Uppsala University Hospital Aarhus University Hospital Sahlgrenska University Hospital, Sweden Ullevaal University Hospital

Transferido a

17 de julho de 2021

DOI

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Licença

Creative Commons BY-NC 4.0
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Eligibility Neuroendocrine Carcinoma NCT02248012

Inglês

Eligibility Neuroendocrine Carcinoma NCT02248012

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven neuroendocrine carcinoma with a ki67 of 20-55%.primary gastroenteropancreatic tumor or cancer of unknown primary where metastases are mainly abdominal measurable disease according to recist by ct/mr
Descrição

Neuroendocrine Carcinoma, Ki67 Measurement | Primary gastroenteropancreatic tumor | Cancer of unknown primary where metastasis are mainly abdominal measurable according to CT/MR

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0206695
UMLS CUI [1,2]
C4049944
UMLS CUI [2,1]
C0475447
UMLS CUI [2,2]
C0017189
UMLS CUI [2,3]
C0030274
UMLS CUI [3,1]
C0027667
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C1513041
UMLS CUI [3,4]
C1542147
UMLS CUI [3,5]
C0017189
UMLS CUI [3,6]
C0024485
UMLS CUI [3,7]
C0040405
>18 years;
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
who/ecog performance status 0-1.
Descrição

Ecog performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate haematological, renal and hepatic functions:
Descrição

Adequate haematological, renal and hepatic functions

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
written informed consent prior to inclusion
Descrição

Informed consent, written

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
prior therapy:
Descrição

Prior therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
no prior chemotherapy treatment for advanced disease.
Descrição

Prior chemotherapy due to advanced disease absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0679246
UMLS CUI [1,4]
C0332197
adjuvant chemotherapy must have ended > 6 months before inclusion.
Descrição

Recent adjuvant chemotherapy absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0332197
prior or current history:
Descrição

Prior or current history

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0009488
no curatively resectable disease;
Descrição

Curatively resectable disease absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C1276305
UMLS CUI [1,4]
C0332197
no other serious illness or medical conditions (including: unstable angina, myocardial infarction within 6 months, unstable diabetes, immune suppression )
Descrição

Other serious illness or medical conditions absent | Unstable angina | Myocardial infarction within 6 months | Unstable diabetes | Immunosuppression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C0332185
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0002965
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0342302
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C4048329
UMLS CUI [6,2]
C0332197
concomitant treatments :
Descrição

Concomitant treatments

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707479
no concomitant (or within 4 weeks before inclusion) administration of any other experimental drug;
Descrição

No concomitant administration of any other experimental drug

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0332197
no other concurrent anti-cancer therapy.
Descrição

No concurrent anti-cancer therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205420
UMLS CUI [1,3]
C0332197
other :
Descrição

ID.16

Tipo de dados

boolean

not pregnant or breast feeding. fertile patients must use adequate contraceptives and fertile females must have a negative pregnancy test.
Descrição

Pregnancy absent | Breastfeeding absent | Fertile patients must use adequate contraceptives | Fertile females must have a negative pregnancy test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0015895
UMLS CUI [2]
C0009871
UMLS CUI [3,1]
C0015895
UMLS CUI [3,2]
C0009871
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0032976
UMLS CUI [4,3]
C0205160
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Similar models

Eligibility Neuroendocrine Carcinoma NCT02248012

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Neuroendocrine Carcinoma, Ki67 Measurement | Primary gastroenteropancreatic tumor | Cancer of unknown primary where metastasis are mainly abdominal measurable according to CT/MR
Item
histologically proven neuroendocrine carcinoma with a ki67 of 20-55%.primary gastroenteropancreatic tumor or cancer of unknown primary where metastases are mainly abdominal measurable disease according to recist by ct/mr
boolean
C0206695 (UMLS CUI [1,1])
C4049944 (UMLS CUI [1,2])
C0475447 (UMLS CUI [2,1])
C0017189 (UMLS CUI [2,2])
C0030274 (UMLS CUI [2,3])
C0027667 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C1513041 (UMLS CUI [3,3])
C1542147 (UMLS CUI [3,4])
C0017189 (UMLS CUI [3,5])
C0024485 (UMLS CUI [3,6])
C0040405 (UMLS CUI [3,7])
Age
Item
>18 years;
boolean
C0001779 (UMLS CUI [1])
Ecog performance status
Item
who/ecog performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
Adequate haematological, renal and hepatic functions
Item
adequate haematological, renal and hepatic functions:
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Informed consent, written
Item
written informed consent prior to inclusion
boolean
C0021430 (UMLS CUI [1])
Prior therapy
Item
prior therapy:
boolean
C1514463 (UMLS CUI [1])
Prior chemotherapy due to advanced disease absent
Item
no prior chemotherapy treatment for advanced disease.
boolean
C1514457 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Recent adjuvant chemotherapy absent
Item
adjuvant chemotherapy must have ended > 6 months before inclusion.
boolean
C0085533 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Prior or current history
Item
prior or current history:
boolean
C0262926 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Curatively resectable disease absent
Item
no curatively resectable disease;
boolean
C0027651 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Other serious illness or medical conditions absent | Unstable angina | Myocardial infarction within 6 months | Unstable diabetes | Immunosuppression
Item
no other serious illness or medical conditions (including: unstable angina, myocardial infarction within 6 months, unstable diabetes, immune suppression )
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0027051 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0002965 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0342302 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C4048329 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Concomitant treatments
Item
concomitant treatments :
boolean
C1707479 (UMLS CUI [1])
No concomitant administration of any other experimental drug
Item
no concomitant (or within 4 weeks before inclusion) administration of any other experimental drug;
boolean
C2347852 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
No concurrent anti-cancer therapy
Item
no other concurrent anti-cancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
ID.16
Item
other :
boolean
Pregnancy absent | Breastfeeding absent | Fertile patients must use adequate contraceptives | Fertile females must have a negative pregnancy test
Item
not pregnant or breast feeding. fertile patients must use adequate contraceptives and fertile females must have a negative pregnancy test.
boolean
C0015895 (UMLS CUI [1])
C0009871 (UMLS CUI [2])
C0015895 (UMLS CUI [3,1])
C0009871 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
C0205160 (UMLS CUI [4,3])
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