ID

18727

Beschreibung

Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00181688

Link

https://clinicaltrials.gov/show/NCT00181688

Stichworte

Versionen (1)
  1. 17.11.16 17.11.16 -
Hochgeladen am

17. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Ovarian Cancer NCT00181688

Englisch

Eligibility Ovarian Cancer NCT00181688

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma
Beschreibung

Ovarian Carcinoma Primary | Primary peritoneal carcinoma | Fallopian Tube Carcinoma Primary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C1514428
UMLS CUI [3,1]
C0238122
UMLS CUI [3,2]
C0205225
asymptomatic from ovarian cancer
Beschreibung

Ovarian Carcinoma Asymptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0231221
evidence of recurrent ovarian, peritoneal or tubal carcinoma
Beschreibung

Ovarian cancer recurrent Evidence of | Carcinoma of peritoneum Recurrent Evidence of | Recurrent Fallopian Tube Carcinoma Evidence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278689
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0948303
UMLS CUI [2,2]
C2945760
UMLS CUI [2,3]
C0332120
UMLS CUI [3,1]
C3897738
UMLS CUI [3,2]
C0332120
tumor sample must be positive for er and/or pr
Beschreibung

Tumor tissue sample Estrogen receptor positive | Tumor tissue sample Progesterone receptor positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0279759
18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of less than or equal to 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
must be able to tolerate oral intake
Beschreibung

Intake Oral Ability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0085732
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to iressa or any of the excipients of this product
Beschreibung

Hypersensitivity Iressa | Hypersensitivity Iressa Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0919281
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0919281
UMLS CUI [2,3]
C0015237
other coexisting malignancies or malignancies diagnosed within the last 5 years
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or st. john's wort
Beschreibung

Phenytoin | Carbamazepine | Barbiturates | Rifampin | Phenobarbital | ST. JOHN'S WORT EXTRACT

Datentyp

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0006949
UMLS CUI [3]
C0004745
UMLS CUI [4]
C0035608
UMLS CUI [5]
C0031412
UMLS CUI [6]
C0813171
treatment with a non-approved or investigational drug within 30 days
Beschreibung

Drugs, Non-Prescription | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0013230
any unresolved chronic toxicity greater than ctc grad 2 from previous anticancer therapy (except alopecia)
Beschreibung

Toxicity chronic Unresolved Due to cancer treatment | CTCAE Grades | Alopecia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0443342
UMLS CUI [1,4]
C0678226
UMLS CUI [1,5]
C0920425
UMLS CUI [2]
C1516728
UMLS CUI [3]
C0002170
incomplete healing from previous oncologic or other major surgery
Beschreibung

cancer surgery | major surgery | Therapeutic procedure Incomplete

Datentyp

boolean

Alias
UMLS CUI [1]
C0920424
UMLS CUI [2]
C0679637
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205257
serum creatinine level greater than ctc grade 2
Beschreibung

Creatinine measurement, serum | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1516728
pregnant or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe uncontrolled systemic disease
Beschreibung

Systemic disease Uncontrolled Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205082
significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
Beschreibung

Disease Significant At risk Study Subject Participation Status | Laboratory finding At risk Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment
Beschreibung

Antineoplastic Agents Investigational | Systemic Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1517586
UMLS CUI [2]
C1883256
UMLS CUI [3]
C1522449
patients previously treated with anastrozole or other aromatase inhibitor
Beschreibung

anastrozole | Aromatase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0290883
UMLS CUI [2]
C0593802
unable to tolerate oral medications
Beschreibung

Oral medication Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
clinical and/or radiographic evidence of current or impending bowel obstruction
Beschreibung

Intestinal Obstruction Evidence Clinical | Intestinal Obstruction Impending Evidence Clinical | Intestinal Obstruction Evidence roentgenographic | Intestinal Obstruction Impending Evidence roentgenographic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021843
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0021843
UMLS CUI [2,2]
C0332190
UMLS CUI [2,3]
C3887511
UMLS CUI [2,4]
C0205210
UMLS CUI [3,1]
C0021843
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0034571
UMLS CUI [4,1]
C0021843
UMLS CUI [4,2]
C0332190
UMLS CUI [4,3]
C3887511
UMLS CUI [4,4]
C0034571
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Ähnliche Modelle

Eligibility Ovarian Cancer NCT00181688

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Ovarian Carcinoma Primary | Primary peritoneal carcinoma | Fallopian Tube Carcinoma Primary
Item
histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma
boolean
C0029925 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1514428 (UMLS CUI [2])
C0238122 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
Ovarian Carcinoma Asymptomatic
Item
asymptomatic from ovarian cancer
boolean
C0029925 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
Ovarian cancer recurrent Evidence of | Carcinoma of peritoneum Recurrent Evidence of | Recurrent Fallopian Tube Carcinoma Evidence of
Item
evidence of recurrent ovarian, peritoneal or tubal carcinoma
boolean
C0278689 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0948303 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
C3897738 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
Tumor tissue sample Estrogen receptor positive | Tumor tissue sample Progesterone receptor positive
Item
tumor sample must be positive for er and/or pr
boolean
C0475358 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of less than or equal to 1
boolean
C1520224 (UMLS CUI [1])
Intake Oral Ability
Item
must be able to tolerate oral intake
boolean
C1512806 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Iressa | Hypersensitivity Iressa Excipient
Item
known hypersensitivity to iressa or any of the excipients of this product
boolean
C0020517 (UMLS CUI [1,1])
C0919281 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0919281 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Malignant Neoplasms
Item
other coexisting malignancies or malignancies diagnosed within the last 5 years
boolean
C0006826 (UMLS CUI [1])
Phenytoin | Carbamazepine | Barbiturates | Rifampin | Phenobarbital | ST. JOHN'S WORT EXTRACT
Item
concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or st. john's wort
boolean
C0031507 (UMLS CUI [1])
C0006949 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0035608 (UMLS CUI [4])
C0031412 (UMLS CUI [5])
C0813171 (UMLS CUI [6])
Drugs, Non-Prescription | Investigational New Drugs
Item
treatment with a non-approved or investigational drug within 30 days
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Toxicity chronic Unresolved Due to cancer treatment | CTCAE Grades | Alopecia
Item
any unresolved chronic toxicity greater than ctc grad 2 from previous anticancer therapy (except alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0443342 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,4])
C0920425 (UMLS CUI [1,5])
C1516728 (UMLS CUI [2])
C0002170 (UMLS CUI [3])
cancer surgery | major surgery | Therapeutic procedure Incomplete
Item
incomplete healing from previous oncologic or other major surgery
boolean
C0920424 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0205257 (UMLS CUI [3,2])
Creatinine measurement, serum | CTCAE Grades
Item
serum creatinine level greater than ctc grade 2
boolean
C0201976 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease Uncontrolled Severe
Item
severe uncontrolled systemic disease
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Disease Significant At risk Study Subject Participation Status | Laboratory finding At risk Study Subject Participation Status
Item
significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0587081 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Antineoplastic Agents Investigational | Systemic Chemotherapy | Therapeutic radiology procedure
Item
patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment
boolean
C0003392 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C1883256 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
anastrozole | Aromatase Inhibitors
Item
patients previously treated with anastrozole or other aromatase inhibitor
boolean
C0290883 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Oral medication Receive Unable
Item
unable to tolerate oral medications
boolean
C0175795 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Intestinal Obstruction Evidence Clinical | Intestinal Obstruction Impending Evidence Clinical | Intestinal Obstruction Evidence roentgenographic | Intestinal Obstruction Impending Evidence roentgenographic
Item
clinical and/or radiographic evidence of current or impending bowel obstruction
boolean
C0021843 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0021843 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C0021843 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
C0021843 (UMLS CUI [4,1])
C0332190 (UMLS CUI [4,2])
C3887511 (UMLS CUI [4,3])
C0034571 (UMLS CUI [4,4])
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