Eligibility Carcinoma, Non-Small-Cell Lung NCT00157196

1 moduli

StudyEvent: Eligibility
1. Eligibility Carcinoma, Non-Small-Cell Lung NCT00157196

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Carcinoma, Non-Small-Cell Lung NCT00157196