ID

18504

Description

Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (With Weekly Low Dose Gemcitabine) in Patients With Lung Cancer With Positive Nodes; ODM derived from: https://clinicaltrials.gov/show/NCT00490659

Link

https://clinicaltrials.gov/show/NCT00490659

Keywords

Versions (1)
  1. 11/8/16 11/8/16 -
Uploaded on

November 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00490659

English

Eligibility Non-Small Cell Lung Cancer NCT00490659

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of nsclc (any subtype). for patients entering arm b is also allowed to confirm histopathological diagnosis of nsclc intraoperatively during this trial.
Description

Non-Small Cell Lung Carcinoma | Non-Small Cell Lung Carcinoma Subtype Any | Non-Small Cell Lung Carcinoma Intraoperative

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0449560
UMLS CUI [2,3]
C1552551
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C0456904
node positive (clinically or pathologically) stage ii disease or stage iiia: t1n1 or t2n1 or t1n2 or t2n2 or t3n1 or t3 n2, according to the revision by mountain cf of american joint committee on cancer (mountain cf 1997, fleming id et al. 1997). for patient entering arm b (with n0 stage) confirmation of n1-n2 stage must be obtained from intraoperative or post-surgery pathology report.
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
tumor amenable to curative surgical resection.
Description

Malignant Neoplasm Amenable Excision Curative

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0728940
UMLS CUI [1,4]
C1276305
patients with clinically measurable lesions will be enrolled in this study. measurability is determined according to recist criteria.
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
• pathological evaluation is performed after mediastinoscopy or after surgery
Description

Evaluation Pathological Post Mediastinoscopy | Evaluation Pathological Post Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0025065
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C1521733
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C0543467
no prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, or any other type of tumor therapy).
Description

cancer treatment | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Molecular Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0021083
UMLS CUI [6]
C2699893
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment within the last 30 days with any investigational drug.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
Description

cancer treatment | Therapeutic radiology procedure | Cytotoxic Chemotherapy | Immunotherapy | Molecular Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0677881
UMLS CUI [4]
C0021083
UMLS CUI [5]
C2699893
serious concomitant disorders (for example, heart failure, poorly controlled diabetes) at the investigator’s discretion.
Description

Comorbidity Serious | Heart failure | poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0554876
presence of an uncontrolled, active infection requiring therapy (at the discretion of investigator.).
Description

Communicable Disease Uncontrolled Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
stage iiib or iv.
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00490659

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Non-Small Cell Lung Carcinoma Subtype Any | Non-Small Cell Lung Carcinoma Intraoperative
Item
histologically or cytologically confirmed diagnosis of nsclc (any subtype). for patients entering arm b is also allowed to confirm histopathological diagnosis of nsclc intraoperatively during this trial.
boolean
C0007131 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0007131 (UMLS CUI [3,1])
C0456904 (UMLS CUI [3,2])
TNM clinical staging
Item
node positive (clinically or pathologically) stage ii disease or stage iiia: t1n1 or t2n1 or t1n2 or t2n2 or t3n1 or t3 n2, according to the revision by mountain cf of american joint committee on cancer (mountain cf 1997, fleming id et al. 1997). for patient entering arm b (with n0 stage) confirmation of n1-n2 stage must be obtained from intraoperative or post-surgery pathology report.
boolean
C3258246 (UMLS CUI [1])
Malignant Neoplasm Amenable Excision Curative
Item
tumor amenable to curative surgical resection.
boolean
C0006826 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C1276305 (UMLS CUI [1,4])
Measurable Disease
Item
patients with clinically measurable lesions will be enrolled in this study. measurability is determined according to recist criteria.
boolean
C1513041 (UMLS CUI [1])
Evaluation Pathological Post Mediastinoscopy | Evaluation Pathological Post Operative Surgical Procedures
Item
• pathological evaluation is performed after mediastinoscopy or after surgery
boolean
C1261322 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0025065 (UMLS CUI [1,4])
C1261322 (UMLS CUI [2,1])
C1521733 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
cancer treatment | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Molecular Targeted Therapy
Item
no prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, or any other type of tumor therapy).
boolean
C0920425 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C2699893 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
treatment within the last 30 days with any investigational drug.
boolean
C0013230 (UMLS CUI [1])
cancer treatment | Therapeutic radiology procedure | Cytotoxic Chemotherapy | Immunotherapy | Molecular Targeted Therapy
Item
concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
boolean
C0920425 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C2699893 (UMLS CUI [5])
Comorbidity Serious | Heart failure | poorly controlled diabetes mellitus
Item
serious concomitant disorders (for example, heart failure, poorly controlled diabetes) at the investigator’s discretion.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0554876 (UMLS CUI [3])
Communicable Disease Uncontrolled Requirement Therapeutic procedure
Item
presence of an uncontrolled, active infection requiring therapy (at the discretion of investigator.).
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
TNM clinical staging
Item
stage iiib or iv.
boolean
C3258246 (UMLS CUI [1])
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