ID

23230

Beschrijving

Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00198133

Link

https://clinicaltrials.gov/show/NCT00198133

Trefwoorden

Versies (1)
  1. 29-06-17 29-06-17 -
Geüploaded op

29 juni 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Thymoma NCT00198133

Engels

Eligibility Thymoma NCT00198133

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Thymoma NCT00198133
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery. original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
Beschrijving

Thymoma invasive | Thymoma recurrent | Thymoma metastatic | Thymic Carcinoma Curative Surgery Unsuccessful | Thymoma Biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0278846
UMLS CUI [2]
C0278848
UMLS CUI [3,1]
C0040100
UMLS CUI [3,2]
C1522484
UMLS CUI [4,1]
C0205969
UMLS CUI [4,2]
C1511562
UMLS CUI [4,3]
C1272705
UMLS CUI [5,1]
C0040100
UMLS CUI [5,2]
C0005558
patients must have measurable disease with at least one bidimensional measurable lesion. any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration.
Beschrijving

Measurable lesion 2-Dimensional Quantity | Measurable Disease Scan | Measurable Disease X-ray

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0441633
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0034571
patients may have had prior chemotherapy for metastatic disease
Beschrijving

Chemotherapy Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0027627
adequate organ function as defined by: bili </=1.5; calc. crt clr of >/=45; hematologic-granulocytes >/=1500 & plt >/=100k.
Beschrijving

Organ function | Serum total bilirubin measurement | Ratio Calcium Creatinine clearance | Hematology | Granulocyte count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C0456603
UMLS CUI [3,2]
C0006675
UMLS CUI [3,3]
C0812399
UMLS CUI [4]
C0200627
UMLS CUI [5]
C0857490
UMLS CUI [6]
C0032181
patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible.
Beschrijving

Adrenal Cortex Hormones Dose Stable | Myasthenia Gravis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0026896
ecog performance status of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute intercurrent infection or complications
Beschrijving

Communicable Disease | Complication

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0009566
pregnancy or lactating patients
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents.
Beschrijving

Aspirin Discontinue Unable | Non-Steroidal Anti-Inflammatory Agents Discontinue Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1299582
presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure
Beschrijving

Body Fluid Space Third Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005889
UMLS CUI [1,2]
C1883067
UMLS CUI [1,3]
C0205437
UMLS CUI [1,4]
C0205318
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Similar models

Eligibility Thymoma NCT00198133

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Thymoma NCT00198133
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Thymoma invasive | Thymoma recurrent | Thymoma metastatic | Thymic Carcinoma Curative Surgery Unsuccessful | Thymoma Biopsy
Item
histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery. original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
boolean
C0278846 (UMLS CUI [1])
C0278848 (UMLS CUI [2])
C0040100 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
C0205969 (UMLS CUI [4,1])
C1511562 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
C0040100 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
Measurable lesion 2-Dimensional Quantity | Measurable Disease Scan | Measurable Disease X-ray
Item
patients must have measurable disease with at least one bidimensional measurable lesion. any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0441633 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0034571 (UMLS CUI [3,2])
Chemotherapy Neoplasm Metastasis
Item
patients may have had prior chemotherapy for metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Organ function | Serum total bilirubin measurement | Ratio Calcium Creatinine clearance | Hematology | Granulocyte count | Platelet Count measurement
Item
adequate organ function as defined by: bili </=1.5; calc. crt clr of >/=45; hematologic-granulocytes >/=1500 & plt >/=100k.
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0456603 (UMLS CUI [3,1])
C0006675 (UMLS CUI [3,2])
C0812399 (UMLS CUI [3,3])
C0200627 (UMLS CUI [4])
C0857490 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
Adrenal Cortex Hormones Dose Stable | Myasthenia Gravis
Item
patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible.
boolean
C0001617 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0026896 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Complication
Item
acute intercurrent infection or complications
boolean
C0009450 (UMLS CUI [1])
C0009566 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or lactating patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Aspirin Discontinue Unable | Non-Steroidal Anti-Inflammatory Agents Discontinue Unable
Item
inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents.
boolean
C0004057 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Body Fluid Space Third Uncontrolled
Item
presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure
boolean
C0005889 (UMLS CUI [1,1])
C1883067 (UMLS CUI [1,2])
C0205437 (UMLS CUI [1,3])
C0205318 (UMLS CUI [1,4])
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