ID

28155

Beskrivning

Phase 2 Study of Enzastaurin With 5 FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00612586

Länk

https://clinicaltrials.gov/show/NCT00612586

Nyckelord

Versioner (1)
  1. 2017-12-22 2017-12-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 december 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00612586

Engelsk

Eligibility Colorectal Cancer NCT00612586

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic diagnosis of locally advanced or metastatic crc that is not curable. the histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. patients with neuroendocrine carcinomas will be excluded.
Beskrivning

Locally Advanced Colorectal Carcinoma Incurable | Colorectal cancer metastatic incurable | Adenocarcinoma | Mucinous Adenocarcinoma | Carcinoma, Signet Ring Cell | Colorectal Undifferentiated Carcinoma | Neuroendocrine Carcinoma Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C0175969
UMLS CUI [2,1]
C0948380
UMLS CUI [2,2]
C0175969
UMLS CUI [3]
C0001418
UMLS CUI [4]
C0007130
UMLS CUI [5]
C0206696
UMLS CUI [6]
C1707443
UMLS CUI [7,1]
C0206695
UMLS CUI [7,2]
C2828389
received 6 cycles (3 months [12 weeks]) of first-line therapy with folfox or folfiri, plus bevacizumab for metastatic crc. patients have received at least 5 cycles with bevacizumab. patients who received 6 cycles of first-line therapy with folfox or folfiri, plus bevacizumab for recurrent crc that has relapsed at least 12 months after completion of adjuvant therapy will also be included. all standard folfox ( or folfiri) regimens given on a biweekly schedule will be permitted; however, 21-day regimens will not be allowed.
Beskrivning

First line treatment Cycle Quantity | FOLFOX Regimen | FOLFIRI Regimen | Bevacizumab | Colorectal cancer metastatic | Colorectal cancer recurrent | Adjuvant therapy Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1302181
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0392943
UMLS CUI [3]
C1880658
UMLS CUI [4]
C0796392
UMLS CUI [5]
C0948380
UMLS CUI [6]
C0854750
UMLS CUI [7,1]
C0677850
UMLS CUI [7,2]
C0205197
no more than 4 weeks may pass between the end of first-line therapy (that is, day 14 of cycle 6) and randomization.
Beskrivning

First line treatment Elapsed Time Randomization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C2826303
UMLS CUI [1,3]
C0034656
documented evidence of tumor response of cr, pr, or sd by computed tomography (ct) scan or magnetic resonance imaging (mri). confirmation of response is not required.
Beskrivning

In complete remission CT scan | Partial response CT scan | Stable Disease CT scan | In complete remission MRI | Partial response MRI | Stable Disease MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0677946
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C0677874
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C1521726
UMLS CUI [5,2]
C0024485
UMLS CUI [6,1]
C0677946
UMLS CUI [6,2]
C0024485
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
are unable to swallow tablets.
Beskrivning

Lacking Able to swallow Tablets

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Beskrivning

Drugs, Non-Prescription

Datatyp

boolean

Alias
UMLS CUI [1]
C0013231
have known central nervous system metastases.
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
are receiving concurrent administration of any other antitumor therapy.
Beskrivning

Cancer treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
patients who have significant heart, liver, kidney, or psychiatric disease or have an active infection
Beskrivning

Heart Disease | Liver disease | Kidney Disease | Mental disorders | Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0009450
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Similar models

Eligibility Colorectal Cancer NCT00612586

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally Advanced Colorectal Carcinoma Incurable | Colorectal cancer metastatic incurable | Adenocarcinoma | Mucinous Adenocarcinoma | Carcinoma, Signet Ring Cell | Colorectal Undifferentiated Carcinoma | Neuroendocrine Carcinoma Excluded
Item
histologic diagnosis of locally advanced or metastatic crc that is not curable. the histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. patients with neuroendocrine carcinomas will be excluded.
boolean
C0009402 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0175969 (UMLS CUI [1,4])
C0948380 (UMLS CUI [2,1])
C0175969 (UMLS CUI [2,2])
C0001418 (UMLS CUI [3])
C0007130 (UMLS CUI [4])
C0206696 (UMLS CUI [5])
C1707443 (UMLS CUI [6])
C0206695 (UMLS CUI [7,1])
C2828389 (UMLS CUI [7,2])
First line treatment Cycle Quantity | FOLFOX Regimen | FOLFIRI Regimen | Bevacizumab | Colorectal cancer metastatic | Colorectal cancer recurrent | Adjuvant therapy Completed
Item
received 6 cycles (3 months [12 weeks]) of first-line therapy with folfox or folfiri, plus bevacizumab for metastatic crc. patients have received at least 5 cycles with bevacizumab. patients who received 6 cycles of first-line therapy with folfox or folfiri, plus bevacizumab for recurrent crc that has relapsed at least 12 months after completion of adjuvant therapy will also be included. all standard folfox ( or folfiri) regimens given on a biweekly schedule will be permitted; however, 21-day regimens will not be allowed.
boolean
C1708063 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0392943 (UMLS CUI [2])
C1880658 (UMLS CUI [3])
C0796392 (UMLS CUI [4])
C0948380 (UMLS CUI [5])
C0854750 (UMLS CUI [6])
C0677850 (UMLS CUI [7,1])
C0205197 (UMLS CUI [7,2])
First line treatment Elapsed Time Randomization
Item
no more than 4 weeks may pass between the end of first-line therapy (that is, day 14 of cycle 6) and randomization.
boolean
C1708063 (UMLS CUI [1,1])
C2826303 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
In complete remission CT scan | Partial response CT scan | Stable Disease CT scan | In complete remission MRI | Partial response MRI | Stable Disease MRI
Item
documented evidence of tumor response of cr, pr, or sd by computed tomography (ct) scan or magnetic resonance imaging (mri). confirmation of response is not required.
boolean
C0677874 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1521726 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0677946 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0677874 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C1521726 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
C0677946 (UMLS CUI [6,1])
C0024485 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Lacking Able to swallow Tablets
Item
are unable to swallow tablets.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Drugs, Non-Prescription
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1])
CNS metastases
Item
have known central nervous system metastases.
boolean
C0686377 (UMLS CUI [1])
Cancer treatment
Item
are receiving concurrent administration of any other antitumor therapy.
boolean
C0920425 (UMLS CUI [1])
Heart Disease | Liver disease | Kidney Disease | Mental disorders | Communicable Disease
Item
patients who have significant heart, liver, kidney, or psychiatric disease or have an active infection
boolean
C0018799 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
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