ID

14606

Beschrijving

Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00212043

Link

https://clinicaltrials.gov/show/NCT00212043

Trefwoorden

Versies (1)
  1. 24-04-16 24-04-16 -
Geüploaded op

24 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00212043

Engels

Eligibility Non Small Cell Lung Cancer NCT00212043

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
• histologically or cytologically confirmed nsclc.
Beschrijving

NSCL

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
stage iiib unsuitable for radical radiation (eg. with cytologically proven malignant effusion) or stage iv disease as defined by the ajcc criteria (see appendix 1).
Beschrijving

Staging

Datatype

boolean

Alias
UMLS CUI [1]
C0278984
UMLS CUI [2]
C0278987
karnofsky performance status 70% or higher (see appendix 2).
Beschrijving

Karnofsky performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
presence of at least one bidimensionally or unidimensionally measurable, non-cns, indicator lesion defined by radiologic study or physical examination.
Beschrijving

Lesion defined by radiologic study or physical examination

Datatype

boolean

Alias
UMLS CUI [1]
C2071490
UMLS CUI [2]
C1290916
UMLS CUI [3]
C0031809
no previous chemotherapy for advanced disease. prior neoadjuvant or adjuvant chemotherapy, or chemotherapy given concurrently with radiotherapy for non-metastatic disease, is allowed if the last dose was given 6 months or more before study entry.
Beschrijving

Chemotherapy or radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
patients with recurrent disease after primary surgery and/or radiotherapy will be eligible.
Beschrijving

Recurrent disease

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
for patients with previous radiotherapy, the indicator lesion(s) must not be within previous radiation field. the last dose of radiotherapy should be at least 3 weeks prior to study entry. the total radiotherapy received should not be more than 30% of the bone marrow.
Beschrijving

Radiotherapy: Specification

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C0449685
UMLS CUI [2,2]
C1882536
UMLS CUI [3]
C2584899
UMLS CUI [4]
C0005953
screening laboratory criteria:
Beschrijving

Laboratory procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0022885
wbc count > 3500/microl neutrophils > 2000/microl platelet count > 100,000/microl hemoglobin > 9 g/dl (transfusion allowed)
Beschrijving

WBC count, neutrophils, platelet count, hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0518015
serum creatinine < 133 micromol/l, or creatinine clearance > 30 ml/min, based on the cockcroft formula (see section 5.1.1)
Beschrijving

Serum creatinine or creatinine clearance

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
bilirubin < 1.5 x upper limit of normal alt/ast < 2 x upper limit of normal if liver metastases are absent < 5 x upper limit of normal if liver metastases are present
Beschrijving

bilirubin, alt/ast, liver metastases

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0494165
aged 18 years and above.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy > 3 months.
Beschrijving

Life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
written informed consent.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
• patients with only evaluable disease.
Beschrijving

Evaluable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1516986
active uncontrolled infection.
Beschrijving

Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or lactating women.
Beschrijving

Gynaecological status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study.
Beschrijving

Contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
presence of any underlying medical conditions which in the investigators opinion would make the patient unsuitable for treatment.
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
concomitant malignancies or previous malignancies other than nsclc within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or stage a low grade prostate cancer.
Beschrijving

Further malignancies

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007114
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C2216722
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0376358
patients with cns and/or leptomeningeal metastases; unless asymptomatic and not receiving corticosteriod therapy.
Beschrijving

CNS and leptomeningeal metastases, corticosteroid therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C1704231
UMLS CUI [3]
C0149783
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00212043

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
NSCL
Item
• histologically or cytologically confirmed nsclc.
boolean
C0007131 (UMLS CUI [1])
Staging
Item
stage iiib unsuitable for radical radiation (eg. with cytologically proven malignant effusion) or stage iv disease as defined by the ajcc criteria (see appendix 1).
boolean
C0278984 (UMLS CUI [1])
C0278987 (UMLS CUI [2])
Karnofsky performance status
Item
karnofsky performance status 70% or higher (see appendix 2).
boolean
C0206065 (UMLS CUI [1])
Lesion defined by radiologic study or physical examination
Item
presence of at least one bidimensionally or unidimensionally measurable, non-cns, indicator lesion defined by radiologic study or physical examination.
boolean
C2071490 (UMLS CUI [1])
C1290916 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Chemotherapy or radiotherapy
Item
no previous chemotherapy for advanced disease. prior neoadjuvant or adjuvant chemotherapy, or chemotherapy given concurrently with radiotherapy for non-metastatic disease, is allowed if the last dose was given 6 months or more before study entry.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Recurrent disease
Item
patients with recurrent disease after primary surgery and/or radiotherapy will be eligible.
boolean
C0277556 (UMLS CUI [1])
Radiotherapy: Specification
Item
for patients with previous radiotherapy, the indicator lesion(s) must not be within previous radiation field. the last dose of radiotherapy should be at least 3 weeks prior to study entry. the total radiotherapy received should not be more than 30% of the bone marrow.
boolean
C1522449 (UMLS CUI [1])
C0449685 (UMLS CUI [2,1])
C1882536 (UMLS CUI [2,2])
C2584899 (UMLS CUI [3])
C0005953 (UMLS CUI [4])
Laboratory procedures
Item
screening laboratory criteria:
boolean
C0022885 (UMLS CUI [1])
WBC count, neutrophils, platelet count, hemoglobin
Item
wbc count > 3500/microl neutrophils > 2000/microl platelet count > 100,000/microl hemoglobin > 9 g/dl (transfusion allowed)
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Serum creatinine or creatinine clearance
Item
serum creatinine < 133 micromol/l, or creatinine clearance > 30 ml/min, based on the cockcroft formula (see section 5.1.1)
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
bilirubin, alt/ast, liver metastases
Item
bilirubin < 1.5 x upper limit of normal alt/ast < 2 x upper limit of normal if liver metastases are absent < 5 x upper limit of normal if liver metastases are present
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
Age
Item
aged 18 years and above.
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
life expectancy > 3 months.
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Evaluable disease
Item
• patients with only evaluable disease.
boolean
C1516986 (UMLS CUI [1])
Infection
Item
active uncontrolled infection.
boolean
C0009450 (UMLS CUI [1])
Gynaecological status
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraception
Item
females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study.
boolean
C0700589 (UMLS CUI [1])
Comorbidity
Item
presence of any underlying medical conditions which in the investigators opinion would make the patient unsuitable for treatment.
boolean
C0009488 (UMLS CUI [1])
Further malignancies
Item
concomitant malignancies or previous malignancies other than nsclc within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or stage a low grade prostate cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007114 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2216722 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0376358 (UMLS CUI [3,3])
CNS and leptomeningeal metastases, corticosteroid therapy
Item
patients with cns and/or leptomeningeal metastases; unless asymptomatic and not receiving corticosteriod therapy.
boolean
C0686377 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
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