ID

22158

Description

A Feasibility Study of Oral Adjuvant Chemotherapy With S-1; ODM derived from: https://clinicaltrials.gov/show/NCT01459185

Link

https://clinicaltrials.gov/show/NCT01459185

Keywords

Versions (2)
  1. 5/21/17 5/21/17 -
  2. 5/22/17 5/22/17 -
Uploaded on

May 21, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Non-small Cell Lung Cancer NCT01459185

English

Eligibility Non-small Cell Lung Cancer NCT01459185

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. nsclc with histological proof.
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
2. pathological stage ib, ii, or iiia nsclc (fifth edition of uicc/ajcc 1997) after complete resection.
Description

Non-Small Cell Lung Carcinoma TNM clinical staging Post Complete excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0015250
3. no prior treatment except for surgery.
Description

Therapy naive | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0543467
4. sufficient oral intake.
Description

Oral food intake Sufficient

Data type

boolean

Alias
UMLS CUI [1,1]
C0518037
UMLS CUI [1,2]
C0205410
5. performance status (ps) 0 or 1.
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
6. patients also had to have adequate organ function (3500 <leukocytes < 12,000/mm3; thrombocytes, >100,000/mm3; total bilirubin,<1.5 mg/dl; ast and alt, less than twice the normal limits at each institution; bun, <25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (ccr))
Description

Organ function | White Blood Cell Count procedure | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0005845
UMLS CUI [8]
C0201976
UMLS CUI [9]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of drug hypersensitivity.
Description

Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0013182
2. contraindication of oral s-1 administration (refer appended paper).
Description

Medical contraindication S-1 Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0879262
UMLS CUI [1,3]
C1527415
3. serious surgical or non-surgical complications
Description

Complication of surgical procedure Serious | Complication Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0274311
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C0205404
4. active secondary cancer.
Description

Secondary Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C3266877
5. watery diarrhea.
Description

Watery diarrhoea

Data type

boolean

Alias
UMLS CUI [1]
C0239182
6. pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. male who has intention to make pregnant
Description

Gender Intent Conception

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C0009637
8. patient to whom primary doctor judged inadequate to register.
Description

Study Subject Participation Status Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205412
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01459185

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. nsclc with histological proof.
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging Post Complete excision
Item
2. pathological stage ib, ii, or iiia nsclc (fifth edition of uicc/ajcc 1997) after complete resection.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0015250 (UMLS CUI [1,4])
Therapy naive | Operative Surgical Procedures
Item
3. no prior treatment except for surgery.
boolean
C0919936 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
Oral food intake Sufficient
Item
4. sufficient oral intake.
boolean
C0518037 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
performance status
Item
5. performance status (ps) 0 or 1.
boolean
C1518965 (UMLS CUI [1])
Organ function | White Blood Cell Count procedure | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Creatinine clearance measurement
Item
6. patients also had to have adequate organ function (3500 <leukocytes < 12,000/mm3; thrombocytes, >100,000/mm3; total bilirubin,<1.5 mg/dl; ast and alt, less than twice the normal limits at each institution; bun, <25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (ccr))
boolean
C0678852 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0005845 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0373595 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Drug Allergy
Item
1. history of drug hypersensitivity.
boolean
C0013182 (UMLS CUI [1])
Medical contraindication S-1 Oral
Item
2. contraindication of oral s-1 administration (refer appended paper).
boolean
C1301624 (UMLS CUI [1,1])
C0879262 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
Complication of surgical procedure Serious | Complication Serious
Item
3. serious surgical or non-surgical complications
boolean
C0274311 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009566 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Secondary Malignant Neoplasm
Item
4. active secondary cancer.
boolean
C3266877 (UMLS CUI [1])
Watery diarrhoea
Item
5. watery diarrhea.
boolean
C0239182 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
6. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Intent Conception
Item
7. male who has intention to make pregnant
boolean
C0079399 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C0009637 (UMLS CUI [1,3])
Study Subject Participation Status Inadequate
Item
8. patient to whom primary doctor judged inadequate to register.
boolean
C2348568 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
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