ID

12818

Beschrijving

Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02088515

Link

https://clinicaltrials.gov/show/NCT02088515

Trefwoorden

Versies (1)
  1. 21-12-15 21-12-15 -
Geüploaded op

21 december 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma NCT02088515

Engels

Eligibility Squamous Cell Carcinoma NCT02088515

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
Beschrijving

lung squamous carcinoma; sputum examination

Datatype

boolean

Alias
UMLS CUI [1]
C0149782
UMLS CUI [2]
C0430356
2. iiib-no radiotherapy indication /iv phased by aslc 2009 tnm criteria.
Beschrijving

radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
3. at least one measurable tumor based on recist ( longest diameter: ≥20 mm by ct scan or 10 mm by spiral ct )
Beschrijving

tumor measurable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1513040
4. male or female, age≥18 or ≤75 years old
Beschrijving

gender; age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
5. ecog ps: 0 or 1
Beschrijving

ecog ps

Datatype

boolean

Alias
UMLS CUI [1]
C1828127
6. estimated time of survival: ≥12 weeks
Beschrijving

time of survival

Datatype

boolean

Alias
UMLS CUI [1]
C2919552
7. suitable hematologic function: anc≥2×109/l, plc≥100×109/l and hb≥9 g/dl
Beschrijving

hematologic function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
8. suitable liver function: total bilirubin≤normal uln, ast and alt≤2.5×normal uln, alp≤5×normal uln.
Beschrijving

liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
9. suitable renal function: cr≤normal uln,or ccr≥60 ml/min
Beschrijving

renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
10. no history of chemotherapy
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
11. at the enrollment, the past operation has been over 4 weeks and the subject recovered.
Beschrijving

operation

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
12. for the female subject with the intact uterus, if amenorrhea is less than 24 months, pregnancy test must be negative within 28 days of enrollment. if pregnancy test has been past 7 days at the time of initial chemotherapy, urine pregnancy test must be done.
Beschrijving

pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
13. the authorized icf must be signed
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. having the other cancer in the recent five years, cured skin basal cell carcinoma and cervical carcinoma excluded.
Beschrijving

comorbidity cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
2. having the evidence of cns metastasis, no matter if treated; if being suspicious of cns metastasis, cns mri or enhanced ct scan must be done within 28 days of enrollment.
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
3. ast and /or alt＞2.5×normal uln, and alp＞5×normal uln.
Beschrijving

Aspartate aminotransferase/Alanine aminotransferase

Datatype

boolean

Alias
UMLS CUI [1]
C0805162
4. radiotherapy in the past (excluding palliative radiotherapy for pain relief and the measurable tumor outside the radio field)
Beschrijving

radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
5. chemotherapy in the past (excluding bisphosphonates )
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
6. having the other uncontrolled diseases.
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
7. the female in pregnancy or feeding.
Beschrijving

pregnancy; lactating

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. the subjects with the productivity capacity, but refusal to use the effective contraception measure.
Beschrijving

contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
9. participating in other clinical trial and at the time of treatment period.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
10. allergy to the tested drugs
Beschrijving

Hypersensitivity study drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
11. having the other uncontrolled diseases
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
12. bmt had been done.
Beschrijving

Bone Marrow Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0005961
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Similar models

Eligibility Squamous Cell Carcinoma NCT02088515

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
lung squamous carcinoma; sputum examination
Item
1. primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
boolean
C0149782 (UMLS CUI [1])
C0430356 (UMLS CUI [2])
radiotherapy
Item
2. iiib-no radiotherapy indication /iv phased by aslc 2009 tnm criteria.
boolean
C1522449 (UMLS CUI [1])
tumor measurable
Item
3. at least one measurable tumor based on recist ( longest diameter: ≥20 mm by ct scan or 10 mm by spiral ct )
boolean
C0006826 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
gender; age
Item
4. male or female, age≥18 or ≤75 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ecog ps
Item
5. ecog ps: 0 or 1
boolean
C1828127 (UMLS CUI [1])
time of survival
Item
6. estimated time of survival: ≥12 weeks
boolean
C2919552 (UMLS CUI [1])
hematologic function
Item
7. suitable hematologic function: anc≥2×109/l, plc≥100×109/l and hb≥9 g/dl
boolean
C0221130 (UMLS CUI [1])
liver function
Item
8. suitable liver function: total bilirubin≤normal uln, ast and alt≤2.5×normal uln, alp≤5×normal uln.
boolean
C0232741 (UMLS CUI [1])
renal function
Item
9. suitable renal function: cr≤normal uln,or ccr≥60 ml/min
boolean
C0232804 (UMLS CUI [1])
chemotherapy
Item
10. no history of chemotherapy
boolean
C0392920 (UMLS CUI [1])
operation
Item
11. at the enrollment, the past operation has been over 4 weeks and the subject recovered.
boolean
C0543467 (UMLS CUI [1])
pregnancy test negative
Item
12. for the female subject with the intact uterus, if amenorrhea is less than 24 months, pregnancy test must be negative within 28 days of enrollment. if pregnancy test has been past 7 days at the time of initial chemotherapy, urine pregnancy test must be done.
boolean
C0427780 (UMLS CUI [1])
informed consent
Item
13. the authorized icf must be signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity cancer
Item
1. having the other cancer in the recent five years, cured skin basal cell carcinoma and cervical carcinoma excluded.
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
CNS metastases
Item
2. having the evidence of cns metastasis, no matter if treated; if being suspicious of cns metastasis, cns mri or enhanced ct scan must be done within 28 days of enrollment.
boolean
C0686377 (UMLS CUI [1])
Aspartate aminotransferase/Alanine aminotransferase
Item
3. ast and /or alt＞2.5×normal uln, and alp＞5×normal uln.
boolean
C0805162 (UMLS CUI [1])
radiotherapy
Item
4. radiotherapy in the past (excluding palliative radiotherapy for pain relief and the measurable tumor outside the radio field)
boolean
C1522449 (UMLS CUI [1])
chemotherapy
Item
5. chemotherapy in the past (excluding bisphosphonates )
boolean
C0392920 (UMLS CUI [1])
comorbidity
Item
6. having the other uncontrolled diseases.
boolean
C0009488 (UMLS CUI [1])
pregnancy; lactating
Item
7. the female in pregnancy or feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
contraceptive methods
Item
8. the subjects with the productivity capacity, but refusal to use the effective contraception measure.
boolean
C0700589 (UMLS CUI [1])
Study Subject Participation Status
Item
9. participating in other clinical trial and at the time of treatment period.
boolean
C2348568 (UMLS CUI [1])
Hypersensitivity study drug
Item
10. allergy to the tested drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
comorbidity
Item
11. having the other uncontrolled diseases
boolean
C0009488 (UMLS CUI [1])
Bone Marrow Transplantation
Item
12. bmt had been done.
boolean
C0005961 (UMLS CUI [1])
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