ID

18321

Beskrivning

A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839; ODM derived from: https://clinicaltrials.gov/show/NCT00212108

Länk

https://clinicaltrials.gov/show/NCT00212108

Nyckelord

  1. 2016-10-31 2016-10-31 -
  2. 2016-10-31 2016-10-31 -
Uppladdad den

31 oktober 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Nasopharyngeal Carcinoma NCT00212108

Eligibility Nasopharyngeal Carcinoma NCT00212108

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven npc.
Beskrivning

Nasopharyngeal carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2931822
2. any clinical stage npc as defined by the ajcc/uicc system.
Beskrivning

Nasopharyngeal carcinoma | TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1]
C2931822
UMLS CUI [2]
C3258246
3. no prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
Beskrivning

Therapeutic radiology procedure | Chemoradiotherapy | Immunotherapy | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0436307
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0013230
4. no prior nsaids or corticosteroids for at least 4 weeks.
Beskrivning

Anti-Inflammatory Agents, Non-Steroidal | Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0001617
5. ecog performance status ≤ 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate end organ function
Beskrivning

organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
7. life expectancy > 3 months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
8. signed informed consent -
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
Beskrivning

ID.9

Datatyp

boolean

2. tumor not visible on fibre nasopharyngoscopy for biopsy.
Beskrivning

ID.10

Datatyp

boolean

3. known peptic ulcer disease.
Beskrivning

Peptic Ulcer

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
4. evidence of clinically active interstitial lung disease.
Beskrivning

ID.12

Datatyp

boolean

5. previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
Beskrivning

ID.13

Datatyp

boolean

6. women who are pregnant or lactating. females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
Beskrivning

ID.14

Datatyp

boolean

7. women of childbearing potential who are not practising adequate contraception.
Beskrivning

Childbearing Potential Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
8. concurrent medical problems that would significantly limit compliance with the study.
Beskrivning

ID.16

Datatyp

boolean

9. presence of any underlying medical conditions (eg. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
Beskrivning

ID.17

Datatyp

boolean

10. known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of nsaids.
Beskrivning

ID.18

Datatyp

boolean

11. known hiv, hbv or hcv infection. -
Beskrivning

ID.19

Datatyp

boolean

Similar models

Eligibility Nasopharyngeal Carcinoma NCT00212108

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma
Item
1. histologically proven npc.
boolean
C2931822 (UMLS CUI [1])
Nasopharyngeal carcinoma | TNM clinical staging
Item
2. any clinical stage npc as defined by the ajcc/uicc system.
boolean
C2931822 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Therapeutic radiology procedure | Chemoradiotherapy | Immunotherapy | Investigational New Drugs
Item
3. no prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
boolean
C1522449 (UMLS CUI [1])
C0436307 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Anti-Inflammatory Agents, Non-Steroidal | Adrenal Cortex Hormones
Item
4. no prior nsaids or corticosteroids for at least 4 weeks.
boolean
C0003211 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
ECOG performance status
Item
5. ecog performance status ≤ 2.
boolean
C1520224 (UMLS CUI [1])
organ function
Item
6. adequate end organ function
boolean
C0678852 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy > 3 months.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
8. signed informed consent -
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.9
Item
1. inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
boolean
ID.10
Item
2. tumor not visible on fibre nasopharyngoscopy for biopsy.
boolean
Peptic Ulcer
Item
3. known peptic ulcer disease.
boolean
C0030920 (UMLS CUI [1])
ID.12
Item
4. evidence of clinically active interstitial lung disease.
boolean
ID.13
Item
5. previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
boolean
ID.14
Item
6. women who are pregnant or lactating. females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
boolean
Childbearing Potential Contraceptive methods Lacking
Item
7. women of childbearing potential who are not practising adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
ID.16
Item
8. concurrent medical problems that would significantly limit compliance with the study.
boolean
ID.17
Item
9. presence of any underlying medical conditions (eg. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
boolean
ID.18
Item
10. known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of nsaids.
boolean
ID.19
Item
11. known hiv, hbv or hcv infection. -
boolean

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