ID

42203

Description

Immunotherapy With Racotumomab Versus Support Treatment in Advanced Non-small Cell Lung Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01240447

Link

https://clinicaltrials.gov/show/NCT01240447

Keywords

Versions (2)
  1. 6/28/16 6/28/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Advanced Non-small Cell Lung Cancer NCT01240447

English

Eligibility Advanced Non-small Cell Lung Cancer NCT01240447

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient (aged over 21 years, either sex) can comply with the protocol and scheduled appointments and sign voluntarily the informed consent form
Description

Informed consent form

Data type

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of non-small cell lung cancer (nsclc) stages iiia (surgically unresectable), iiib or iv, according to the tnm classification (tumor-nodes-metastases) version 6a, confirmed by cytology or histology, if possible available for determination of ganglioside expression
Description

non-small cell lung cancer

Data type

boolean

Alias
UMLS CUI [1]
C0007131
patients may enter the study if they have accomplished an objective response (complete response or partial response) or disease stabilisation (by response evaluation criteria in solid tumours [recist]) after completion of standard onco-specific treatment. in all cases, response should be documented.
Description

response

Data type

boolean

Alias
UMLS CUI [1]
C0521982
for stage iiia and iiib without pleural effusion ("dry iiib") standard treatment is considered as follows: 2 - 4 cycles of platinum-based chemotherapy and/or radiotherapy with curative intent in accordance with national comprehensive cancer network (nccn) guidelines for stage iiib with pleural effusion ("wet iiib") and stage iv standard treatment is considered as follows: 4 - 6 cycles of chemotherapy based on platinum. in case of pleural or pericardial effusion requiring local treatment, it will be provided prior to study entry.
Description

chemotherapy curative

Data type

boolean

Alias
UMLS CUI [1]
C0392920
patients with an interval greater than 30 and not more than 90 days between the completion of oncospecific treatment and study entry. completion of treatment is defined as the last day of administration of chemotherapy or the last day of radiotherapy. patients should have recovered from any related episode of acute toxicity of degree greater than 1 (except alopecia). patients who have received a monoclonal antibody (eg bevacizumab) should also have discontinued its use for at least 30 days before inclusion.
Description

interval

Data type

boolean

Alias
UMLS CUI [1]
C1531784
the subject is male or female, aged greater than or equal to 21 years
Description

age, sex

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
performance status (eastern cooperative oncology group [ecog]) less than or equal to 1
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
acceptable organ functionality as defined by the following parameters:
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
electrocardiogram (ecg) without significant abnormalities, performed within 14 days prior to admission
Description

ecg

Data type

boolean

Alias
UMLS CUI [1]
C1623258
haemoglobin greater than or equal to 90 g/l
Description

hb

Data type

boolean

Alias
UMLS CUI [1]
C0518015
total leukocyte count greater than or equal to 3.0 x 10^9/l
Description

leukocyte count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count greater than or equal to 1.5 x 10^9/l
Description

absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
total bilirubin less than or equal to 1.5 times upper limit of normal or twice the limit normal than in case liver metastases are present
Description

total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201913
serum glutamic oxaloacetic transaminase (sgot) and serum glutamic pyruvic transaminase (sgpt) less than or equal to 2.5 times upper limit of normal (less than or equal to five times the normal maximum in case liver metastases are present)
Description

sgot

Data type

boolean

Alias
UMLS CUI [1]
C0201899
creatinine less than or equal to 2 mg/dl
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0010294
life expectancy of at least four months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is pregnant or breastfeeding
Description

pregnant or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
has received chemotherapy, radiotherapy, immunotherapy or surgery within 30 days prior to inclusion
Description

chemotherapy, radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
hypersensitivity to any component of the formulation
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
patients of childbearing potential of either sex who are not using an adequate method of contraception during treatment to avoid pregnancy (own or of partner). for females: intrauterine devices, hormonal contraceptives, barrier methods or sterilisation. for males: vasectomy or condoms with spermicide.
Description

method of contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
patients receiving or having received other investigational drugs 30 days prior to study entry
Description

investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
history of autoimmune diseases
Description

autoimmune diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004364
decompensated chronic diseases
Description

chronic disease

Data type

boolean

Alias
UMLS CUI [1]
C0008679
acute allergic disorders or history of severe allergic reactions
Description

allergic disorder

Data type

boolean

Alias
UMLS CUI [1]
C1527304
known brain metastases uncontrolled with surgery and/or radiation therapy or under current corticosteroid therapy
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
history of inflammatory or demyelinating disease of the central or peripheral nervous system
Description

demyelinating disease, inflammatory disease

Data type

boolean

Alias
UMLS CUI [1]
C0007860
UMLS CUI [2]
C0011303
uncontrolled intercurrent illnesses, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric diseases implying patient incompetence
Description

intercurrent illnesses

Data type

boolean

Alias
UMLS CUI [1]
C0277557
other malignancies, with the exception of basal cell carcinoma, in situ cervical carcinoma, incidental prostate cancer (t1a, gleason less than or equal to 6, prostate specific antigen [psa] less than 0.5 ng/ml), tumour or any other tumour adequately treated and with a disease-free period greater than or equal to 5 years
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
chronic treatment with systemic corticosteroids at doses greater than 0.5 mg/kg/day or a maximum of 40 mg/day of prednisone or equivalent
Description

systemic corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C4039704
the subject has a history of drug abuse (illicit drugs) or alcohol abuse (defined as regular or periodic ingestion of more than four drinks a day) in the last 2 years
Description

substance abuse disorder

Data type

boolean

Alias
UMLS CUI [1]
C1537075
positive serology for hepatitis b, c or known human immunodeficiency virus (hiv) infection
Description

hepatitis b, c or known human immunodeficiency virus (hiv)

Data type

boolean

Alias
UMLS CUI [1,1]
C2711110
UMLS CUI [1,2]
C0019682
uncontrolled hypercalcaemia greater than or equal to 2.9 mmol/l (or grade greater than 1 according to the common terminology criteria for adverse events [ctcae] version 3.0)
Description

uncontrolled hypercalcaemia

Data type

boolean

Alias
UMLS CUI [1]
C0020437
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Similar models

Eligibility Advanced Non-small Cell Lung Cancer NCT01240447

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent form
Item
the patient (aged over 21 years, either sex) can comply with the protocol and scheduled appointments and sign voluntarily the informed consent form
boolean
C0021430 (UMLS CUI [1])
non-small cell lung cancer
Item
diagnosis of non-small cell lung cancer (nsclc) stages iiia (surgically unresectable), iiib or iv, according to the tnm classification (tumor-nodes-metastases) version 6a, confirmed by cytology or histology, if possible available for determination of ganglioside expression
boolean
C0007131 (UMLS CUI [1])
response
Item
patients may enter the study if they have accomplished an objective response (complete response or partial response) or disease stabilisation (by response evaluation criteria in solid tumours [recist]) after completion of standard onco-specific treatment. in all cases, response should be documented.
boolean
C0521982 (UMLS CUI [1])
chemotherapy curative
Item
for stage iiia and iiib without pleural effusion ("dry iiib") standard treatment is considered as follows: 2 - 4 cycles of platinum-based chemotherapy and/or radiotherapy with curative intent in accordance with national comprehensive cancer network (nccn) guidelines for stage iiib with pleural effusion ("wet iiib") and stage iv standard treatment is considered as follows: 4 - 6 cycles of chemotherapy based on platinum. in case of pleural or pericardial effusion requiring local treatment, it will be provided prior to study entry.
boolean
C0392920 (UMLS CUI [1])
interval
Item
patients with an interval greater than 30 and not more than 90 days between the completion of oncospecific treatment and study entry. completion of treatment is defined as the last day of administration of chemotherapy or the last day of radiotherapy. patients should have recovered from any related episode of acute toxicity of degree greater than 1 (except alopecia). patients who have received a monoclonal antibody (eg bevacizumab) should also have discontinued its use for at least 30 days before inclusion.
boolean
C1531784 (UMLS CUI [1])
age, sex
Item
the subject is male or female, aged greater than or equal to 21 years
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
ecog
Item
performance status (eastern cooperative oncology group [ecog]) less than or equal to 1
boolean
C1520224 (UMLS CUI [1])
organ function
Item
acceptable organ functionality as defined by the following parameters:
boolean
C0678852 (UMLS CUI [1])
ecg
Item
electrocardiogram (ecg) without significant abnormalities, performed within 14 days prior to admission
boolean
C1623258 (UMLS CUI [1])
hb
Item
haemoglobin greater than or equal to 90 g/l
boolean
C0518015 (UMLS CUI [1])
leukocyte count
Item
total leukocyte count greater than or equal to 3.0 x 10^9/l
boolean
C0023508 (UMLS CUI [1])
absolute neutrophil count
Item
absolute neutrophil count greater than or equal to 1.5 x 10^9/l
boolean
C0200633 (UMLS CUI [1])
total bilirubin
Item
total bilirubin less than or equal to 1.5 times upper limit of normal or twice the limit normal than in case liver metastases are present
boolean
C0201913 (UMLS CUI [1])
sgot
Item
serum glutamic oxaloacetic transaminase (sgot) and serum glutamic pyruvic transaminase (sgpt) less than or equal to 2.5 times upper limit of normal (less than or equal to five times the normal maximum in case liver metastases are present)
boolean
C0201899 (UMLS CUI [1])
creatinine
Item
creatinine less than or equal to 2 mg/dl
boolean
C0010294 (UMLS CUI [1])
life expectancy
Item
life expectancy of at least four months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or breastfeeding
Item
patient is pregnant or breastfeeding
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
chemotherapy, radiotherapy
Item
has received chemotherapy, radiotherapy, immunotherapy or surgery within 30 days prior to inclusion
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
hypersensitivity
Item
hypersensitivity to any component of the formulation
boolean
C0020517 (UMLS CUI [1])
method of contraception
Item
patients of childbearing potential of either sex who are not using an adequate method of contraception during treatment to avoid pregnancy (own or of partner). for females: intrauterine devices, hormonal contraceptives, barrier methods or sterilisation. for males: vasectomy or condoms with spermicide.
boolean
C0700589 (UMLS CUI [1])
investigational drug
Item
patients receiving or having received other investigational drugs 30 days prior to study entry
boolean
C0013230 (UMLS CUI [1])
autoimmune diseases
Item
history of autoimmune diseases
boolean
C0004364 (UMLS CUI [1])
chronic disease
Item
decompensated chronic diseases
boolean
C0008679 (UMLS CUI [1])
allergic disorder
Item
acute allergic disorders or history of severe allergic reactions
boolean
C1527304 (UMLS CUI [1])
brain metastases
Item
known brain metastases uncontrolled with surgery and/or radiation therapy or under current corticosteroid therapy
boolean
C0220650 (UMLS CUI [1])
demyelinating disease, inflammatory disease
Item
history of inflammatory or demyelinating disease of the central or peripheral nervous system
boolean
C0007860 (UMLS CUI [1])
C0011303 (UMLS CUI [2])
intercurrent illnesses
Item
uncontrolled intercurrent illnesses, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric diseases implying patient incompetence
boolean
C0277557 (UMLS CUI [1])
malignancies
Item
other malignancies, with the exception of basal cell carcinoma, in situ cervical carcinoma, incidental prostate cancer (t1a, gleason less than or equal to 6, prostate specific antigen [psa] less than 0.5 ng/ml), tumour or any other tumour adequately treated and with a disease-free period greater than or equal to 5 years
boolean
C0006826 (UMLS CUI [1])
systemic corticosteroids
Item
chronic treatment with systemic corticosteroids at doses greater than 0.5 mg/kg/day or a maximum of 40 mg/day of prednisone or equivalent
boolean
C4039704 (UMLS CUI [1])
substance abuse disorder
Item
the subject has a history of drug abuse (illicit drugs) or alcohol abuse (defined as regular or periodic ingestion of more than four drinks a day) in the last 2 years
boolean
C1537075 (UMLS CUI [1])
hepatitis b, c or known human immunodeficiency virus (hiv)
Item
positive serology for hepatitis b, c or known human immunodeficiency virus (hiv) infection
boolean
C2711110 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
uncontrolled hypercalcaemia
Item
uncontrolled hypercalcaemia greater than or equal to 2.9 mmol/l (or grade greater than 1 according to the common terminology criteria for adverse events [ctcae] version 3.0)
boolean
C0020437 (UMLS CUI [1])
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