ID

27029

Beschrijving

F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00992706

Link

https://clinicaltrials.gov/show/NCT00992706

Trefwoorden

Versies (1)
  1. 30-10-17 30-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00992706

Engels

Eligibility Breast Cancer NCT00992706

1 Formulieren  
Criteria
Beschrijving

Criteria

diagnosis of metastatic breast cancer
Beschrijving

Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0346993
no cutaneous metastases on hands or feet
Beschrijving

Exclusion Criteria | Secondary malignant neoplasm of skin Hand | Secondary malignant neoplasm of skin Foot

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0153687
UMLS CUI [2,2]
C0018563
UMLS CUI [3,1]
C0153687
UMLS CUI [3,2]
C0016504
pegylated liposomal doxorubicin hydrochloride monotherapy is indicated according to the local investigator
Beschrijving

Indication Pegylated liposomal doxorubicin hydrochloride

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1522690
planned dose at least 10 mg/m^2 per week
Beschrijving

Planned Dose U/week

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826283
UMLS CUI [1,2]
C0560588
no sign of palmar-plantar erythrodysesthesia (ppe) at study entry
Beschrijving

Exclusion | Sign Palmar-plantar erythrodysesthesia

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0549410
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
who performance status 0-2
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
able to apply topical medication (cream) or provide for another person to apply cream
Beschrijving

Ability Apply Topical Cream

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C4048755
UMLS CUI [1,3]
C0991551
not pregnant or breastfeeding
Beschrijving

Exclusion Criteria | Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
fertile patients must use effective contraception during trial participation and for 1 month after completion
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
compliant and geographically proximal in order to allow proper evaluation and follow-up
Beschrijving

Compliance behavior Evaluation | Compliance behavior Follow-up | Patients Geographic Proximal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1261322
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1517526
UMLS CUI [3,3]
C0205107
no dermatologic conditions (e.g., psoriasis) that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
Beschrijving

Exclusion Criteria | Dermatologic disorders Affecting Hand | Dermatologic disorders Affecting Foot | Dermatologic disorders Complicating Evaluation | Psoriasis

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0018563
UMLS CUI [3,1]
C0037274
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0016504
UMLS CUI [4,1]
C0037274
UMLS CUI [4,2]
C1522701
UMLS CUI [4,3]
C1261322
UMLS CUI [5]
C0033860
no known allergy or hypersensitivity to f511 cream
Beschrijving

Exclusion | Hypersensitivity Cream F511

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2981805
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschrijving

ID.16

Datatype

boolean

more than 30 days since prior and no concurrent treatment with other experimental drugs or anticancer therapy
Beschrijving

Exclusion Criteria | Investigational New Drugs | Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0920425
more than 30 days since prior and no concurrent treatment on another clinical trial
Beschrijving

Exclusion | Study Subject Participation Status | Therapies, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0949266
no concurrent local use of other ointments or creams for hands or feet other than excipial repair®
Beschrijving

Exclusion Criteria | Ointments Hand Use of Local | Ointments Foot Use of Local | Cream Hand Use of Local | Cream Foot Use of Local | Exception Cream Specified

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0028912
UMLS CUI [2,2]
C0018563
UMLS CUI [2,3]
C1524063
UMLS CUI [2,4]
C0205276
UMLS CUI [3,1]
C0028912
UMLS CUI [3,2]
C0016504
UMLS CUI [3,3]
C1524063
UMLS CUI [3,4]
C0205276
UMLS CUI [4,1]
C3494477
UMLS CUI [4,2]
C0018563
UMLS CUI [4,3]
C1524063
UMLS CUI [4,4]
C0205276
UMLS CUI [5,1]
C3494477
UMLS CUI [5,2]
C0016504
UMLS CUI [5,3]
C1524063
UMLS CUI [5,4]
C0205276
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C3494477
UMLS CUI [6,3]
C0205369
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Similar models

Eligibility Breast Cancer NCT00992706

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Secondary malignant neoplasm of female breast
Item
diagnosis of metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Exclusion Criteria | Secondary malignant neoplasm of skin Hand | Secondary malignant neoplasm of skin Foot
Item
no cutaneous metastases on hands or feet
boolean
C0680251 (UMLS CUI [1])
C0153687 (UMLS CUI [2,1])
C0018563 (UMLS CUI [2,2])
C0153687 (UMLS CUI [3,1])
C0016504 (UMLS CUI [3,2])
Indication Pegylated liposomal doxorubicin hydrochloride
Item
pegylated liposomal doxorubicin hydrochloride monotherapy is indicated according to the local investigator
boolean
C3146298 (UMLS CUI [1,1])
C1522690 (UMLS CUI [1,2])
Planned Dose U/week
Item
planned dose at least 10 mg/m^2 per week
boolean
C2826283 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
Exclusion | Sign Palmar-plantar erythrodysesthesia
Item
no sign of palmar-plantar erythrodysesthesia (ppe) at study entry
boolean
C2828389 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C0549410 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Ability Apply Topical Cream
Item
able to apply topical medication (cream) or provide for another person to apply cream
boolean
C0085732 (UMLS CUI [1,1])
C4048755 (UMLS CUI [1,2])
C0991551 (UMLS CUI [1,3])
Exclusion Criteria | Pregnancy | Breast Feeding
Item
not pregnant or breastfeeding
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during trial participation and for 1 month after completion
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Compliance behavior Evaluation | Compliance behavior Follow-up | Patients Geographic Proximal
Item
compliant and geographically proximal in order to allow proper evaluation and follow-up
boolean
C1321605 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C1517526 (UMLS CUI [3,2])
C0205107 (UMLS CUI [3,3])
Exclusion Criteria | Dermatologic disorders Affecting Hand | Dermatologic disorders Affecting Foot | Dermatologic disorders Complicating Evaluation | Psoriasis
Item
no dermatologic conditions (e.g., psoriasis) that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
boolean
C0680251 (UMLS CUI [1])
C0037274 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0018563 (UMLS CUI [2,3])
C0037274 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0016504 (UMLS CUI [3,3])
C0037274 (UMLS CUI [4,1])
C1522701 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0033860 (UMLS CUI [5])
Exclusion | Hypersensitivity Cream F511
Item
no known allergy or hypersensitivity to f511 cream
boolean
C2828389 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2981805 (UMLS CUI [2,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.16
Item
see disease characteristics
boolean
Exclusion Criteria | Investigational New Drugs | Cancer treatment
Item
more than 30 days since prior and no concurrent treatment with other experimental drugs or anticancer therapy
boolean
C0680251 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
Exclusion | Study Subject Participation Status | Therapies, Investigational
Item
more than 30 days since prior and no concurrent treatment on another clinical trial
boolean
C2828389 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Exclusion Criteria | Ointments Hand Use of Local | Ointments Foot Use of Local | Cream Hand Use of Local | Cream Foot Use of Local | Exception Cream Specified
Item
no concurrent local use of other ointments or creams for hands or feet other than excipial repair®
boolean
C0680251 (UMLS CUI [1])
C0028912 (UMLS CUI [2,1])
C0018563 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
C0205276 (UMLS CUI [2,4])
C0028912 (UMLS CUI [3,1])
C0016504 (UMLS CUI [3,2])
C1524063 (UMLS CUI [3,3])
C0205276 (UMLS CUI [3,4])
C3494477 (UMLS CUI [4,1])
C0018563 (UMLS CUI [4,2])
C1524063 (UMLS CUI [4,3])
C0205276 (UMLS CUI [4,4])
C3494477 (UMLS CUI [5,1])
C0016504 (UMLS CUI [5,2])
C1524063 (UMLS CUI [5,3])
C0205276 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C3494477 (UMLS CUI [6,2])
C0205369 (UMLS CUI [6,3])
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