ID

31164

Beschrijving

A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00885963

Link

https://clinicaltrials.gov/show/NCT00885963

Trefwoorden

Versies (1)
  1. 24-07-18 24-07-18 -
Houder van rechten

See clinicaltrials.gov

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24 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00885963

Engels

Eligibility Non-small Cell Lung Cancer NCT00885963

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed recurrent nsclc
Beschrijving

Non-small cell lung cancer recurrent

Datatype

boolean

Alias
UMLS CUI [1]
C0278517
age of 18 years or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
measurable disease according to recist
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in part a of the study only.
Beschrijving

Prior Chemotherapy Quantity Neoplasm Metastasis | Prior Chemotherapy Quantity Recurrent disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0277556
adequate bone marrow function
Beschrijving

Bone Marrow function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
adequate renal function
Beschrijving

Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
adequate liver function
Beschrijving

Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
at least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities
Beschrijving

Systemic therapy Previous | Cancer treatment Investigational Previous | Prior radiation therapy | Toxicity Previous Patient recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0205156
UMLS CUI [3]
C0279134
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C1115804
at least 3 weeks from major surgery
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
patient must be able to swallow capsules
Beschrijving

Able to swallow Capsules

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Beschrijving

Contraceptive methods | Exception Infertility Documented

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021359
UMLS CUI [2,3]
C1301725
ability to understand and willingness to sign the informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
nsclc histology contains a component of small cell lung cancer
Beschrijving

Non-Small Cell Lung Carcinoma Histology Containing Component Small cell carcinoma of lung

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C4048239
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C1705248
UMLS CUI [1,5]
C0149925
previously untreated cns metastasis or progressive cns metastasis documented by mri scan performed at 4 weeks or longer after the last treatment for cns metastasis
Beschrijving

CNS metastases untreated | CNS metastases Progressive MRI scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0205329
UMLS CUI [2,3]
C0024485
currently receiving radiotherapy, biological therapy, or any other investigational agents
Beschrijving

Therapeutic radiology procedure | Biological treatment | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0013230
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Beschrijving

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
cancer other than nsclc that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
Beschrijving

Chemotherapy Cancer Other | Biological treatment Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Hormone Therapy Neoadjuvant allowed | Hormone Therapy Adjuvant allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C0279025
UMLS CUI [6,2]
C0600558
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C0279025
UMLS CUI [7,2]
C1522673
UMLS CUI [7,3]
C0683607
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known to be hiv-positive
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00885963

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell lung cancer recurrent
Item
histologically or cytologically confirmed recurrent nsclc
boolean
C0278517 (UMLS CUI [1])
Age
Item
age of 18 years or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to recist
boolean
C1513041 (UMLS CUI [1])
Prior Chemotherapy Quantity Neoplasm Metastasis | Prior Chemotherapy Quantity Recurrent disease
Item
had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in part a of the study only.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0277556 (UMLS CUI [2,3])
Bone Marrow function
Item
adequate bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
Liver function
Item
adequate liver function
boolean
C0232741 (UMLS CUI [1])
Systemic therapy Previous | Cancer treatment Investigational Previous | Prior radiation therapy | Toxicity Previous Patient recovered
Item
at least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities
boolean
C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1115804 (UMLS CUI [4,3])
Major surgery
Item
at least 3 weeks from major surgery
boolean
C0679637 (UMLS CUI [1])
Able to swallow Capsules
Item
patient must be able to swallow capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Contraceptive methods | Exception Infertility Documented
Item
agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
boolean
C0700589 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
C1301725 (UMLS CUI [2,3])
Informed Consent
Item
ability to understand and willingness to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-Small Cell Lung Carcinoma Histology Containing Component Small cell carcinoma of lung
Item
nsclc histology contains a component of small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C4048239 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C0149925 (UMLS CUI [1,5])
CNS metastases untreated | CNS metastases Progressive MRI scan
Item
previously untreated cns metastasis or progressive cns metastasis documented by mri scan performed at 4 weeks or longer after the last treatment for cns metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Therapeutic radiology procedure | Biological treatment | Investigational New Drugs
Item
currently receiving radiotherapy, biological therapy, or any other investigational agents
boolean
C1522449 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Chemotherapy Cancer Other | Biological treatment Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Hormone Therapy Neoadjuvant allowed | Hormone Therapy Adjuvant allowed
Item
cancer other than nsclc that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
boolean
C0392920 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C1707251 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C0279025 (UMLS CUI [6,1])
C0600558 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0279025 (UMLS CUI [7,1])
C1522673 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
known to be hiv-positive
boolean
C0019699 (UMLS CUI [1])
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