ID

13197

Description

A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00201344

Link

https://clinicaltrials.gov/show/NCT00201344

Keywords

Versions (1)
  1. 1/23/16 1/23/16 -
Uploaded on

January 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT00201344

English

Eligibility Nasopharyngeal Carcinoma NCT00201344

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
Description

nasopharyngeal carcinoma, radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C2931822
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1276305
original stage must be stage iv disease (m0)
Description

Tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
Description

Response to treatment, stable disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C1522449
UMLS CUI [2]
C0677946
performance status scale ecog grade 0，1.
Description

Ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, wbc ≧ 3,000/mm3 and plt ≧ 100,000/mm3,
Description

creatinine, bilirubin, wbc and plt

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0005821
creatinine clearance ＞ 45ml/min if creatinine ＞ 1.5mg/dl.
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
patients must be younger than 70 year-old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must give signed informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients had progressive disease after radiotherapy
Description

progressive disease

Data type

boolean

Alias
UMLS CUI [1]
C1335499
patients had evidence of distant metastasis.
Description

distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
patients had completed radiotherapy for more than 7 weeks.
Description

radiotherapy completion

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0011008
the presence of life-threatening illness
Description

life-threatening illness

Data type

boolean

Alias
UMLS CUI [1]
C0009488
history of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of npc cancer.
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
previous chemotherapy.
Description

previous chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
pregnancy.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT00201344

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
nasopharyngeal carcinoma, radiotherapy
Item
patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
boolean
C2931822 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
Tumor stage
Item
original stage must be stage iv disease (m0)
boolean
C1300072 (UMLS CUI [1])
Response to treatment, stable disease
Item
patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
boolean
C0521982 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0677946 (UMLS CUI [2])
Ecog
Item
performance status scale ecog grade 0，1.
boolean
C1520224 (UMLS CUI [1])
creatinine, bilirubin, wbc and plt
Item
creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, wbc ≧ 3,000/mm3 and plt ≧ 100,000/mm3,
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
creatinine clearance
Item
creatinine clearance ＞ 45ml/min if creatinine ＞ 1.5mg/dl.
boolean
C0373595 (UMLS CUI [1])
Age
Item
patients must be younger than 70 year-old.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
patients must give signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
progressive disease
Item
patients had progressive disease after radiotherapy
boolean
C1335499 (UMLS CUI [1])
distant metastasis
Item
patients had evidence of distant metastasis.
boolean
C1269798 (UMLS CUI [1])
radiotherapy completion
Item
patients had completed radiotherapy for more than 7 weeks.
boolean
C1522449 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
life-threatening illness
Item
the presence of life-threatening illness
boolean
C0009488 (UMLS CUI [1])
malignancies
Item
history of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of npc cancer.
boolean
C0006826 (UMLS CUI [1])
previous chemotherapy
Item
previous chemotherapy.
boolean
C0392920 (UMLS CUI [1])
pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
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