ID

14609

Description

Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00913705

Link

https://clinicaltrials.gov/show/NCT00913705

Keywords

Versions (1)
  1. 4/24/16 4/24/16 -
Uploaded on

April 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Cancer NCT00913705

English

Eligibility Non-Small-Cell Lung Cancer NCT00913705

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patients eligible for the study are those with a diagnosis, histologically or cytologically proven, of nsclc without metastases at stages ib, iia, iib and iiia (not n2) of the disease. patients with stage ia and tumor size >2cm will be eligible as well.
Description

Non-small cell lung cancer

Data type

boolean

Alias
UMLS CUI [1]
C0280217
patients aged > 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
tumor considered resectable by the attending surgeon.
Description

Resectable tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C1514888
UMLS CUI [1,2]
C0027651
the patient must have an ecog *2 or karnofsky >60%.
Description

ECOG and karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
the patients need to have adequate hematological, renal and hepatic function defined as:
Description

Hematological, renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0541533
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
absolute neutrophil counts (anc*) *1.5 x 109/l platelet counts *100 x 109/l total bilirubin *1.25 x upper limit of normal distribution serum creatinine <120 umol/l (<1.5 mg/dl) creatinine clearance >60 ml/min
Description

Laboratory tests

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0373595
anc = segmented neutrophils + banded neutrophils
Description

ANC: specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C2348235
the patients should have recovered from any serious surgical sequellae.
Description

Health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
informed consent must be obtained from the patient in accordance with the requirements of the irb/ec.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
if female, the patient must not be pregnant or breast-feeding. women of child bearing potential need to have a pregnancy test performed and to take appropriate contraceptive action during the period of the study.
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032976
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0700589
operability criteria: lung function test will be performed so as to confirm a predictive postoperative value of fev-1 >-800 ml, i.e. correct homeostasis. a carbon monoxide diffusion test is to be conducted and, when applicable, repeated following the induction treatment while taking into account the sensitivity of post-chemotherapy pulmonary toxicity detection.
Description

Operability criteria

Data type

boolean

Alias
UMLS CUI [1]
C0016529
UMLS CUI [2]
C0019868
UMLS CUI [3]
C1516251
UMLS CUI [4]
C0439577
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have previously been treated with chemotherapy and/or radiotherapy.
Description

Chemotherapy and radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
history of significant cardiovascular disease such as non-controlled hypertension, unstable angina or congestive heart failure even if these are controlled by medication. documented history of acute myocardial infarction in the previous year, ventricular arrhythmias that required medication or 2nd or 3rd atrial-ventricular blocks.
Description

Cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
pre-existing sensory or motor neurotoxicity grade >2 based on the who criteria.
Description

Sensory or motor neurotoxicity grade

Data type

boolean

Alias
UMLS CUI [1]
C0442874
UMLS CUI [2]
C0235032
active infection or other clinical state that could seriously reduce the patient's capacity to tolerate the treatment protocol, including previous allergic reactions to products containing cremophor (e.g. cyclosporin or vitamin k).
Description

Comorbidty and allergies

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0020517
previous or concomitant malignant tumor (with the exception of in situ cervical carcinoma, baso-cellular carcinoma, squamous cell skin carcinoma or urothelial superficial carcinoma) which are considered potentially curable with oncological treatment and have a disease free survival (dfs) greater than 5 years excepting breast cancer, melanoma and hypernephroma
Description

Concomitant malignant tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0243087
UMLS CUI [1,2]
C0006826
marked psychoses or senility
Description

Psychoses or senility

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0231337
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Similar models

Eligibility Non-Small-Cell Lung Cancer NCT00913705

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell lung cancer
Item
the patients eligible for the study are those with a diagnosis, histologically or cytologically proven, of nsclc without metastases at stages ib, iia, iib and iiia (not n2) of the disease. patients with stage ia and tumor size >2cm will be eligible as well.
boolean
C0280217 (UMLS CUI [1])
Age
Item
patients aged > 18 years.
boolean
C0001779 (UMLS CUI [1])
Resectable tumor
Item
tumor considered resectable by the attending surgeon.
boolean
C1514888 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
ECOG and karnofsky performance status
Item
the patient must have an ecog *2 or karnofsky >60%.
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Hematological, renal and hepatic function
Item
the patients need to have adequate hematological, renal and hepatic function defined as:
boolean
C0541533 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Laboratory tests
Item
absolute neutrophil counts (anc*) *1.5 x 109/l platelet counts *100 x 109/l total bilirubin *1.25 x upper limit of normal distribution serum creatinine <120 umol/l (<1.5 mg/dl) creatinine clearance >60 ml/min
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
ANC: specification
Item
anc = segmented neutrophils + banded neutrophils
boolean
C0948762 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Health status
Item
the patients should have recovered from any serious surgical sequellae.
boolean
C0018759 (UMLS CUI [1])
Informed consent
Item
informed consent must be obtained from the patient in accordance with the requirements of the irb/ec.
boolean
C0021430 (UMLS CUI [1])
Gynaecological status
Item
if female, the patient must not be pregnant or breast-feeding. women of child bearing potential need to have a pregnancy test performed and to take appropriate contraceptive action during the period of the study.
boolean
C0032961 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Operability criteria
Item
operability criteria: lung function test will be performed so as to confirm a predictive postoperative value of fev-1 >-800 ml, i.e. correct homeostasis. a carbon monoxide diffusion test is to be conducted and, when applicable, repeated following the induction treatment while taking into account the sensitivity of post-chemotherapy pulmonary toxicity detection.
boolean
C0016529 (UMLS CUI [1])
C0019868 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
C0439577 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Chemotherapy and radiotherapy
Item
patients who have previously been treated with chemotherapy and/or radiotherapy.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Cardiac function
Item
history of significant cardiovascular disease such as non-controlled hypertension, unstable angina or congestive heart failure even if these are controlled by medication. documented history of acute myocardial infarction in the previous year, ventricular arrhythmias that required medication or 2nd or 3rd atrial-ventricular blocks.
boolean
C0232164 (UMLS CUI [1])
Sensory or motor neurotoxicity grade
Item
pre-existing sensory or motor neurotoxicity grade >2 based on the who criteria.
boolean
C0442874 (UMLS CUI [1])
C0235032 (UMLS CUI [2])
Comorbidty and allergies
Item
active infection or other clinical state that could seriously reduce the patient's capacity to tolerate the treatment protocol, including previous allergic reactions to products containing cremophor (e.g. cyclosporin or vitamin k).
boolean
C0009488 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
Concomitant malignant tumor
Item
previous or concomitant malignant tumor (with the exception of in situ cervical carcinoma, baso-cellular carcinoma, squamous cell skin carcinoma or urothelial superficial carcinoma) which are considered potentially curable with oncological treatment and have a disease free survival (dfs) greater than 5 years excepting breast cancer, melanoma and hypernephroma
boolean
C0243087 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Psychoses or senility
Item
marked psychoses or senility
boolean
C0033975 (UMLS CUI [1])
C0231337 (UMLS CUI [2])
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