ID

16460

Beschreibung

Safety Study of BLP25 Liposome Vaccine in Non-Small Cell Lung Cancer Patients With Unresectable Stage III Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00157196

Link

https://clinicaltrials.gov/show/NCT00157196

Stichworte

Versionen (1)
  1. 17.07.16 17.07.16 -
Hochgeladen am

17. Juli 2016

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00157196

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT00157196

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented unresectable stage iii nsclc. mediastinal (n2) involvement must be confirmed by biopsy
Beschreibung

NSCLC

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage iii disease
Beschreibung

stable disease or clinical response after primary therapy of chemo-radiation treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2,1]
C4055223
UMLS CUI [2,2]
C0436307
primary therapy should be a minimum of 2 cycles of platinum-based first-line chemotherapy, given concurrent with thoracic radiation. the combined modality should consist of either:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
induction (2 cycles) chemotherapy followed by concurrent chemo/rt; or
Beschreibung

Concurrent Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009429
concurrent chemo/rt followed by 2 cycles of consolidation chemotherapy; or
Beschreibung

Concurrent Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009429
concurrent chemo/rt alone
Beschreibung

Concurrent Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009429
a minimum radiation dose of ≥6,000cgy should be administered. patients must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry
Beschreibung

Radiation dosage

Datentyp

boolean

Alias
UMLS CUI [1]
C0034620
ecog performance status of ≤1
Beschreibung

ECOG

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
ability to understand and willingness to sign a written informed consent
Beschreibung

written informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
undergone lung cancer specific therapy (including surgery) prior to primary chemo/rt
Beschreibung

Prior lung cancer specific therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0242379
received immunotherapy within 4 weeks prior to study entry
Beschreibung

Prior immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
received systemic immunosuppressive drugs within 4 weeks prior to study entry
Beschreibung

Systemic immunosuppressive agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205373
received investigational systemic drugs within 4 weeks prior to study entry
Beschreibung

Investigational systemic drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205373
brain metastases
Beschreibung

Brain metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
pleural effusion, unless cytologically confirmed to be non-malignant
Beschreibung

Malignant pleural effusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0080032
past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
Beschreibung

Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C0027651
autoimmune disease or immunodeficiency
Beschreibung

Autoimmune disease or immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
clinically significant hepatic, renal or cardiac dysfunction
Beschreibung

Hepatic, renal or cardiac dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
clinically significant active infection
Beschreibung

Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
Beschreibung

pregnant or lactating, women of childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT00157196

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
NSCLC
Item
histologically documented unresectable stage iii nsclc. mediastinal (n2) involvement must be confirmed by biopsy
boolean
C0007131 (UMLS CUI [1])
stable disease or clinical response after primary therapy of chemo-radiation treatment
Item
stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage iii disease
boolean
C0677946 (UMLS CUI [1])
C4055223 (UMLS CUI [2,1])
C0436307 (UMLS CUI [2,2])
Therapeutic procedure
Item
primary therapy should be a minimum of 2 cycles of platinum-based first-line chemotherapy, given concurrent with thoracic radiation. the combined modality should consist of either:
boolean
C0087111 (UMLS CUI [1])
Concurrent Therapy
Item
induction (2 cycles) chemotherapy followed by concurrent chemo/rt; or
boolean
C0009429 (UMLS CUI [1])
Concurrent Therapy
Item
concurrent chemo/rt followed by 2 cycles of consolidation chemotherapy; or
boolean
C0009429 (UMLS CUI [1])
Concurrent Therapy
Item
concurrent chemo/rt alone
boolean
C0009429 (UMLS CUI [1])
Radiation dosage
Item
a minimum radiation dose of ≥6,000cgy should be administered. patients must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry
boolean
C0034620 (UMLS CUI [1])
ECOG
Item
ecog performance status of ≤1
boolean
C1520224 (UMLS CUI [1])
written informed consent
Item
ability to understand and willingness to sign a written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior lung cancer specific therapy
Item
undergone lung cancer specific therapy (including surgery) prior to primary chemo/rt
boolean
C1514463 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
Prior immunotherapy
Item
received immunotherapy within 4 weeks prior to study entry
boolean
C0021083 (UMLS CUI [1])
Systemic immunosuppressive agents
Item
received systemic immunosuppressive drugs within 4 weeks prior to study entry
boolean
C0021081 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Investigational systemic drug
Item
received investigational systemic drugs within 4 weeks prior to study entry
boolean
C0013230 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Brain metastases
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Malignant pleural effusion
Item
pleural effusion, unless cytologically confirmed to be non-malignant
boolean
C0080032 (UMLS CUI [1])
Neoplasm
Item
past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
boolean
C0027651 (UMLS CUI [1])
Autoimmune disease or immunodeficiency
Item
autoimmune disease or immunodeficiency
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Hepatic, renal or cardiac dysfunction
Item
clinically significant hepatic, renal or cardiac dysfunction
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
Infection
Item
clinically significant active infection
boolean
C0009450 (UMLS CUI [1])
pregnant or lactating, women of childbearing potential
Item
pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
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