ID

16671

Description

An Open, Randomized, Multicentre, Phase II Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00293085

Link

https://clinicaltrials.gov/show/NCT00293085

Keywords

Versions (1)
  1. 7/31/16 7/31/16 -
Uploaded on

July 31, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00293085

English

Eligibility Non-Small Cell Lung Cancer NCT00293085

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented nsclc stage i-ii
Description

nsclc stage

Data type

boolean

Alias
UMLS CUI [1]
C0278504
UMLS CUI [2]
C0278505
complete resection of tumor amd resection margins microscopically tumor free.
Description

r0 resection

Data type

boolean

Alias
UMLS CUI [1]
C0015250
surgical procedure: according to necessity for oncology radicality a lobectomy, bilobectomy or pneumectomy will be performed with either radical mediastinal lymphadenectomy or complete sampling of all relevant lymph node areas.
Description

lobectomy, bilobectomy or pneumectomy

Data type

boolean

Alias
UMLS CUI [1]
C0023928
UMLS CUI [2]
C0396580
UMLS CUI [3]
C0032284
randomization within 60 days after surgical required.
Description

randomization within 60 days after surgical required.

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0032790
initial work-up
Description

ID.5

Data type

boolean

general conditions: 19-70 years, who performance status 0-2, adequate hematological function, adequate renal and hepatic function, negative pregnancy test.
Description

general conditions

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1298651
UMLS CUI [3]
C0678852
UMLS CUI [4]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
nsclc stage ii-iv, sclc or alveolar carcinoma
Description

nsclc stage ii-iv, sclc or alveolar carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278506
UMLS CUI [2]
C0278987
UMLS CUI [3]
C0149925
UMLS CUI [4]
C0007120
clinical evidence of cns metastases
Description

cns metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
pregnant and lactating patients
Description

pregnant and lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
past or concurrent history of malignancies other than nsclc,except for curatively treated non melanoma of the skin or in situ cervical carcinoma or other curatively treated cancer with no evidence of disease for at least five years.
Description

past or concurrent history of malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
prior or concurrent antitumor therapy for nsclc other than surgery.
Description

prior or concurrent antitumor therapy for nsclc other than surgery

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
concomitant participation in clinical studies of non-approved experimental agents or procedures.
Description

clinical trial participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
major complications after surgery
Description

major complications after surgery

Data type

boolean

Alias
UMLS CUI [1]
C0032787
serious concomitant medical conditions
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
psychological,familial, sociological or geographical conditions which do not permit compliance with the study protocol
Description

study compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0348080
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00293085

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
nsclc stage
Item
histologically documented nsclc stage i-ii
boolean
C0278504 (UMLS CUI [1])
C0278505 (UMLS CUI [2])
r0 resection
Item
complete resection of tumor amd resection margins microscopically tumor free.
boolean
C0015250 (UMLS CUI [1])
lobectomy, bilobectomy or pneumectomy
Item
surgical procedure: according to necessity for oncology radicality a lobectomy, bilobectomy or pneumectomy will be performed with either radical mediastinal lymphadenectomy or complete sampling of all relevant lymph node areas.
boolean
C0023928 (UMLS CUI [1])
C0396580 (UMLS CUI [2])
C0032284 (UMLS CUI [3])
randomization within 60 days after surgical required.
Item
randomization within 60 days after surgical required.
boolean
C0034656 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
ID.5
Item
initial work-up
boolean
general conditions
Item
general conditions: 19-70 years, who performance status 0-2, adequate hematological function, adequate renal and hepatic function, negative pregnancy test.
boolean
C0001779 (UMLS CUI [1])
C1298651 (UMLS CUI [2])
C0678852 (UMLS CUI [3])
C0427780 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
nsclc stage ii-iv, sclc or alveolar carcinoma
Item
nsclc stage ii-iv, sclc or alveolar carcinoma
boolean
C0278506 (UMLS CUI [1])
C0278987 (UMLS CUI [2])
C0149925 (UMLS CUI [3])
C0007120 (UMLS CUI [4])
cns metastases
Item
clinical evidence of cns metastases
boolean
C0686377 (UMLS CUI [1])
pregnant and lactating
Item
pregnant and lactating patients
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
past or concurrent history of malignancies
Item
past or concurrent history of malignancies other than nsclc,except for curatively treated non melanoma of the skin or in situ cervical carcinoma or other curatively treated cancer with no evidence of disease for at least five years.
boolean
C0006826 (UMLS CUI [1])
prior or concurrent antitumor therapy for nsclc other than surgery
Item
prior or concurrent antitumor therapy for nsclc other than surgery.
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
clinical trial participation status
Item
concomitant participation in clinical studies of non-approved experimental agents or procedures.
boolean
C2348568 (UMLS CUI [1])
major complications after surgery
Item
major complications after surgery
boolean
C0032787 (UMLS CUI [1])
comorbidity
Item
serious concomitant medical conditions
boolean
C0009488 (UMLS CUI [1])
study compliance
Item
psychological,familial, sociological or geographical conditions which do not permit compliance with the study protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
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