ID

12818

Description

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

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma NCT02088515

English

Eligibility Squamous Cell Carcinoma NCT02088515

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

lung squamous carcinoma; sputum examination

Data type

boolean

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

radiotherapy

Data type

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 )
Description

tumor measurable

Data type

boolean

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

gender; age

Data type

boolean

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

ecog ps

Data type

boolean

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

time of survival

Data type

boolean

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

hematologic function

Data type

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.
Description

liver function

Data type

boolean

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

renal function

Data type

boolean

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

chemotherapy

Data type

boolean

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

operation

Data type

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.
Description

pregnancy test negative

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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.
Description

comorbidity cancer

Data type

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.
Description

CNS metastases

Data type

boolean

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

Aspartate aminotransferase/Alanine aminotransferase

Data type

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)
Description

radiotherapy

Data type

boolean

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

chemotherapy

Data type

boolean

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

comorbidity

Data type

boolean

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

pregnancy; lactating

Data type

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.
Description

contraceptive methods

Data type

boolean

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

Study Subject Participation Status

Data type

boolean

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

Hypersensitivity study drug

Data type

boolean

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

comorbidity

Data type

boolean

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

Bone Marrow Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0005961
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Similar models

Eligibility Squamous Cell Carcinoma NCT02088515

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