ID

42480

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02248012

Nyckelord

Versioner (1)
  1. 2021-07-17 2021-07-17 -
Rättsinnehavare

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

Uppladdad den

17 juli 2021

DOI

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Licens

Creative Commons BY-NC 4.0
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Eligibility Neuroendocrine Carcinoma NCT02248012

Engelsk

Eligibility Neuroendocrine Carcinoma NCT02248012

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

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

Datatyp

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;
Beskrivning

Age

Datatyp

boolean

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

Ecog performance status

Datatyp

boolean

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

Adequate haematological, renal and hepatic functions

Datatyp

boolean

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

Informed consent, written

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
prior therapy:
Beskrivning

Prior therapy

Datatyp

boolean

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

Prior chemotherapy due to advanced disease absent

Datatyp

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.
Beskrivning

Recent adjuvant chemotherapy absent

Datatyp

boolean

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

Prior or current history

Datatyp

boolean

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

Curatively resectable disease absent

Datatyp

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 )
Beskrivning

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

Datatyp

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 :
Beskrivning

Concomitant treatments

Datatyp

boolean

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

No concomitant administration of any other experimental drug

Datatyp

boolean

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

No concurrent anti-cancer therapy

Datatyp

boolean

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

ID.16

Datatyp

boolean

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

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

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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