ID

18321

Description

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

Link

https://clinicaltrials.gov/show/NCT00212108

Keywords

  1. 10/31/16 10/31/16 -
  2. 10/31/16 10/31/16 -
Uploaded on

October 31, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Nasopharyngeal Carcinoma NCT00212108

Eligibility Nasopharyngeal Carcinoma NCT00212108

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven npc.
Description

Nasopharyngeal carcinoma

Data type

boolean

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

Nasopharyngeal carcinoma | TNM clinical staging

Data type

boolean

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

Therapeutic radiology procedure | Chemoradiotherapy | Immunotherapy | Investigational New Drugs

Data type

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.
Description

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

Data type

boolean

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

ECOG performance status

Data type

boolean

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

organ function

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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.
Description

ID.9

Data type

boolean

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

ID.10

Data type

boolean

3. known peptic ulcer disease.
Description

Peptic Ulcer

Data type

boolean

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

ID.12

Data type

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.
Description

ID.13

Data type

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.
Description

ID.14

Data type

boolean

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

Childbearing Potential Contraceptive methods Lacking

Data type

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.
Description

ID.16

Data type

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.
Description

ID.17

Data type

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.
Description

ID.18

Data type

boolean

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

ID.19

Data type

boolean

Similar models

Eligibility Nasopharyngeal Carcinoma NCT00212108

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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