ID

31020

Beschreibung

Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01086488

Link

https://clinicaltrials.gov/show/NCT01086488

Stichworte

Versionen (1)
  1. 11.07.18 11.07.18 -
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See clinicaltrials.gov

Hochgeladen am

11. Juli 2018

DOI

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Eligibility Nasopharyngeal Carcinoma NCT01086488

Englisch

Eligibility Nasopharyngeal Carcinoma NCT01086488

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will be deemed eligible for inclusion if all the following criteria are met.
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
histologically confirmed local or locoregional recurrent or persistent npc, [t1-2a, n1-2; m0] at least 3 months following a full course of irradiation
Beschreibung

Nasopharyngeal cancer recurrent Local TNM clinical staging | Nasopharyngeal carcinoma Persistent Local TNM clinical staging | Nasopharyngeal cancer recurrent Locoregional TNM clinical staging | Nasopharyngeal carcinoma Persistent Locoregional TNM clinical staging | Disease length Post Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278952
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C2931822
UMLS CUI [2,2]
C0205322
UMLS CUI [2,3]
C0205276
UMLS CUI [2,4]
C3258246
UMLS CUI [3,1]
C0278952
UMLS CUI [3,2]
C1947913
UMLS CUI [3,3]
C3258246
UMLS CUI [4,1]
C2931822
UMLS CUI [4,2]
C0205322
UMLS CUI [4,3]
C1947913
UMLS CUI [4,4]
C3258246
UMLS CUI [5,1]
C0872146
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C1522449
discrete tumour, less or equal to 15 mm in depth, which is endoscopically visible and accessible for unrestricted surface illumination using a nasopharyngeal applicator, with no bony invasion
Beschreibung

Tumor Discrete Depth | Tumor Visible Endoscopy | Tumor Amenable Illumination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0443299
UMLS CUI [1,3]
C0205125
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0205379
UMLS CUI [2,3]
C0014245
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C3900053
UMLS CUI [3,3]
C1964256
patient is 18 - 69 years of age, and legally competent
Beschreibung

Age | Legal capacity

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0683673
patient has a ecog performance status ≤2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patient is a man or a non-pregnant, non-lactating woman
Beschreibung

Gender | Pregnancy Absent | Breast Feeding Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
patient, or his legally appointed representative, is able and willing to provide informed consent to participate in the study
Beschreibung

Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will not be deemed eligible for inclusion if any of the following criteria apply.
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
elective surgery is planned for within 30 days of administration of foscan®
Beschreibung

Elective Surgical Procedures Planned | Foscan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0701505
patient has any disease, which is caused or exacerbated by light, including systemic lupus erythematosus, psoriasis, porphyria, actinic reticuloid or xeroderma pigmentosum
Beschreibung

Disease caused by Light | Disease Exacerbation Due to Light | Lupus Erythematosus, Systemic | Psoriasis | Porphyria | Actinic reticuloid | Xeroderma Pigmentosum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0023693
UMLS CUI [2,1]
C0235874
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0023693
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0033860
UMLS CUI [5]
C3463940
UMLS CUI [6]
C0282309
UMLS CUI [7]
C0043346
patient has been treated within the prior 30 days with a light-activated therapy or other medication that may render the patient photosensitive (e.g., psoralen ultraviolet a-range [puva], accutane)
Beschreibung

Phototherapy | Pharmaceutical Preparations Relationship Photosensitivity of skin | PUVA | Accutane

Datentyp

boolean

Alias
UMLS CUI [1]
C0031765
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0349506
UMLS CUI [3]
C0853073
UMLS CUI [4]
C0699581
patient has received prior photodynamic therapy to the proposed treatment site within the prior 3 months
Beschreibung

Photochemotherapy Treatment site

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031740
UMLS CUI [1,2]
C0337950
patient has co-existing ophthalmic disease, which is likely to require slit lamp examination within 30 days following foscan® administration
Beschreibung

Comorbidity ophthalmic Requirement Slit lamp biomicroscopy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0015392
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0419360
patient has a known hypersensitivity to temoporfin, or any of the excipients, or to porphyrins
Beschreibung

Hypersensitivity Temoporfin | Hypersensitivity Temoporfin Excipient | Hypersensitivity Porphyrins

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0379149
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0379149
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0032712
patient has a tumour known to be eroding into a major blood vessel in, or adjacent to, the proposed illumination site
Beschreibung

Tumor Impairing Blood Vessel Major | Tumor Impairing Illumination Site

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0205164
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C1964256
UMLS CUI [2,4]
C1515974
patient is of childbearing potential and will not use adequate contraceptive protection. patient should practice strict birth control (oestrogen-containing oral contraceptives or an intrauterine device) throughout the study. only post-menopausal women (at least 2 years since the onset of the menopause) and women who have had a hysterectomy are exempt from the requirement to use birth control.
Beschreibung

Childbearing Potential Contraceptive methods Unwilling | Patients Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Exception Postmenopausal state | Exception Hysterectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0009907
UMLS CUI [4]
C0021900
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0232970
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0020699
patient has received treatment with an experimental drug within the prior 30 days
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
patient has received radiotherapy to the head and neck region within the prior 3 months
Beschreibung

Radiation therapy to the head and neck

Datentyp

boolean

Alias
UMLS CUI [1]
C4540910
patient is not willing or able to complete the visit requirements of this protocol or adhere to the instructions regarding light exposure
Beschreibung

Protocol Compliance Unwilling | Protocol Compliance Unable | Exposure to light Instructions Adherence Unwilling | Exposure to light Instructions Adherence Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C1689916
UMLS CUI [3,2]
C1442085
UMLS CUI [3,3]
C1510802
UMLS CUI [3,4]
C0558080
UMLS CUI [4,1]
C1689916
UMLS CUI [4,2]
C1442085
UMLS CUI [4,3]
C1510802
UMLS CUI [4,4]
C1299582
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Ähnliche Modelle

Eligibility Nasopharyngeal Carcinoma NCT01086488

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients will be deemed eligible for inclusion if all the following criteria are met.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Nasopharyngeal cancer recurrent Local TNM clinical staging | Nasopharyngeal carcinoma Persistent Local TNM clinical staging | Nasopharyngeal cancer recurrent Locoregional TNM clinical staging | Nasopharyngeal carcinoma Persistent Locoregional TNM clinical staging | Disease length Post Therapeutic radiology procedure
Item
histologically confirmed local or locoregional recurrent or persistent npc, [t1-2a, n1-2; m0] at least 3 months following a full course of irradiation
boolean
C0278952 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C2931822 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C0278952 (UMLS CUI [3,1])
C1947913 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
C2931822 (UMLS CUI [4,1])
C0205322 (UMLS CUI [4,2])
C1947913 (UMLS CUI [4,3])
C3258246 (UMLS CUI [4,4])
C0872146 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
Tumor Discrete Depth | Tumor Visible Endoscopy | Tumor Amenable Illumination
Item
discrete tumour, less or equal to 15 mm in depth, which is endoscopically visible and accessible for unrestricted surface illumination using a nasopharyngeal applicator, with no bony invasion
boolean
C0027651 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0205379 (UMLS CUI [2,2])
C0014245 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C3900053 (UMLS CUI [3,2])
C1964256 (UMLS CUI [3,3])
Age | Legal capacity
Item
patient is 18 - 69 years of age, and legally competent
boolean
C0001779 (UMLS CUI [1])
C0683673 (UMLS CUI [2])
ECOG performance status
Item
patient has a ecog performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent
Item
patient is a man or a non-pregnant, non-lactating woman
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent | Informed Consent Patient Representative
Item
patient, or his legally appointed representative, is able and willing to provide informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will not be deemed eligible for inclusion if any of the following criteria apply.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Elective Surgical Procedures Planned | Foscan
Item
elective surgery is planned for within 30 days of administration of foscan®
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0701505 (UMLS CUI [2])
Disease caused by Light | Disease Exacerbation Due to Light | Lupus Erythematosus, Systemic | Psoriasis | Porphyria | Actinic reticuloid | Xeroderma Pigmentosum
Item
patient has any disease, which is caused or exacerbated by light, including systemic lupus erythematosus, psoriasis, porphyria, actinic reticuloid or xeroderma pigmentosum
boolean
C0012634 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0023693 (UMLS CUI [1,3])
C0235874 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0023693 (UMLS CUI [2,3])
C0024141 (UMLS CUI [3])
C0033860 (UMLS CUI [4])
C3463940 (UMLS CUI [5])
C0282309 (UMLS CUI [6])
C0043346 (UMLS CUI [7])
Phototherapy | Pharmaceutical Preparations Relationship Photosensitivity of skin | PUVA | Accutane
Item
patient has been treated within the prior 30 days with a light-activated therapy or other medication that may render the patient photosensitive (e.g., psoralen ultraviolet a-range [puva], accutane)
boolean
C0031765 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0349506 (UMLS CUI [2,3])
C0853073 (UMLS CUI [3])
C0699581 (UMLS CUI [4])
Photochemotherapy Treatment site
Item
patient has received prior photodynamic therapy to the proposed treatment site within the prior 3 months
boolean
C0031740 (UMLS CUI [1,1])
C0337950 (UMLS CUI [1,2])
Comorbidity ophthalmic Requirement Slit lamp biomicroscopy
Item
patient has co-existing ophthalmic disease, which is likely to require slit lamp examination within 30 days following foscan® administration
boolean
C0009488 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0419360 (UMLS CUI [1,4])
Hypersensitivity Temoporfin | Hypersensitivity Temoporfin Excipient | Hypersensitivity Porphyrins
Item
patient has a known hypersensitivity to temoporfin, or any of the excipients, or to porphyrins
boolean
C0020517 (UMLS CUI [1,1])
C0379149 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0379149 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0032712 (UMLS CUI [3,2])
Tumor Impairing Blood Vessel Major | Tumor Impairing Illumination Site
Item
patient has a tumour known to be eroding into a major blood vessel in, or adjacent to, the proposed illumination site
boolean
C0027651 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0027651 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C1964256 (UMLS CUI [2,3])
C1515974 (UMLS CUI [2,4])
Childbearing Potential Contraceptive methods Unwilling | Patients Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Exception Postmenopausal state | Exception Hysterectomy
Item
patient is of childbearing potential and will not use adequate contraceptive protection. patient should practice strict birth control (oestrogen-containing oral contraceptives or an intrauterine device) throughout the study. only post-menopausal women (at least 2 years since the onset of the menopause) and women who have had a hysterectomy are exempt from the requirement to use birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0009907 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0232970 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0020699 (UMLS CUI [6,2])
Investigational New Drugs
Item
patient has received treatment with an experimental drug within the prior 30 days
boolean
C0013230 (UMLS CUI [1])
Radiation therapy to the head and neck
Item
patient has received radiotherapy to the head and neck region within the prior 3 months
boolean
C4540910 (UMLS CUI [1])
Protocol Compliance Unwilling | Protocol Compliance Unable | Exposure to light Instructions Adherence Unwilling | Exposure to light Instructions Adherence Unable
Item
patient is not willing or able to complete the visit requirements of this protocol or adhere to the instructions regarding light exposure
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C1689916 (UMLS CUI [3,1])
C1442085 (UMLS CUI [3,2])
C1510802 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
C1689916 (UMLS CUI [4,1])
C1442085 (UMLS CUI [4,2])
C1510802 (UMLS CUI [4,3])
C1299582 (UMLS CUI [4,4])
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