ID

38612

Descrizione

Clinical Study of Microdosing Carboplatin in Lung or Bladder Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01261299

collegamento

https://clinicaltrials.gov/show/NCT01261299

Keywords

versioni (1)
  1. 28/10/19 28/10/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

28 ottobre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Carcinoma, Non-Small-Cell Lung NCT01261299

Inglese

Eligibility Carcinoma, Non-Small-Cell Lung NCT01261299

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must have clinical diagnosis of lung or bladder cancer. the term "clinical diagnosis" means that patients are diagnosed with nsclc or bladder transitional cell carcinoma (tcc) based on imaging studies, but will need further biopsy/resection to obtain tissue in order to confirm the diagnosis. however, some patients may not have cancer as determined by pathology examination of the tissue, or may have a different cancer after biopsy/resection is performed. if the diagnosis of nsclc or bladder cancer is confirmed, platinum-based chemotherapy must be planned either for neoadjuvant chemotherapy for stage ii or above bladder cancer, or palliative therapy for stage iii or iv lung or bladder cancer regardless of patient participation in this study. stage ii or above tcc patients and stage iv nsclc patients that will receive platinum-based chemotherapy will be eligible for this study. patients with stage iii or iv lung or bladder cancer must have measurable lesion(s).
Descrizione

Non-Small Cell Lung Carcinoma Imaging study | Transitional cell carcinoma of bladder Imaging study | Biopsy Obtain Tissue specimen | Resection Obtain Tissue specimen | Platinum-based chemotherapy Planned | Neoadjuvant Chemotherapy Carcinoma of bladder TNM clinical staging | Palliative therapy Carcinoma of lung TNM clinical staging | Palliative therapy Carcinoma of bladder TNM clinical staging | Platinum-based chemotherapy Transitional cell carcinoma of bladder TNM clinical staging | Platinum-based chemotherapy Non-Small Cell Lung Carcinoma TNM clinical staging | Carcinoma of lung TNM clinical staging Measurable lesion | Carcinoma of bladder TNM clinical staging Measurable lesion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1881134
UMLS CUI [2,1]
C0279680
UMLS CUI [2,2]
C1881134
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C1301820
UMLS CUI [3,3]
C1292533
UMLS CUI [4,1]
C0728940
UMLS CUI [4,2]
C1301820
UMLS CUI [4,3]
C1292533
UMLS CUI [5,1]
C3536920
UMLS CUI [5,2]
C1301732
UMLS CUI [6,1]
C0600558
UMLS CUI [6,2]
C3665472
UMLS CUI [6,3]
C0699885
UMLS CUI [6,4]
C3258246
UMLS CUI [7,1]
C0030231
UMLS CUI [7,2]
C0684249
UMLS CUI [7,3]
C3258246
UMLS CUI [8,1]
C0030231
UMLS CUI [8,2]
C0699885
UMLS CUI [8,3]
C3258246
UMLS CUI [9,1]
C3536920
UMLS CUI [9,2]
C0279680
UMLS CUI [9,3]
C3258246
UMLS CUI [10,1]
C3536920
UMLS CUI [10,2]
C0007131
UMLS CUI [10,3]
C3258246
UMLS CUI [11,1]
C0684249
UMLS CUI [11,2]
C3258246
UMLS CUI [11,3]
C1513041
UMLS CUI [12,1]
C0699885
UMLS CUI [12,2]
C3258246
UMLS CUI [12,3]
C1513041
prior radiation or surgery is allowed, but should be finished at least 2 weeks prior to study enrollment. if a participant has prior radiation therapy, at least one measurable lesion outside of the radiation field should be available for the evaluation of response to chemotherapy.
Descrizione

Prior radiation therapy Completed | Prior surgery Completed | Measurable lesion Quantity Evaluation | Exception Lesion Radiation Field

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0455610
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0220825
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0221198
UMLS CUI [4,3]
C1882536
participants must be 18 years or older. we do not see any patients with nsclc or bladder tcc are diagnosed under the age of 18 years.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status equal or less than to 2 (karnofsky equal to or greater than 50%).
Descrizione

ECOG performance status | Karnofsky Performance Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
life expectancy of at least 3 months.
Descrizione

Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023671
participants must have normal organ and marrow function as defined below: absolute neutrophil count greater than/equal to 1,500/microl; platelet count greater than/equal to 100,000/microl; total bilirubin less than 1.5 x uln; ast (sgot) less than/equal to 2.5 x uln; creatinine less than 1.5 x uln
Descrizione

Organ function | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201976
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation.
Descrizione

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
ability to understand and willing to sign a written informed consent document.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not receive concomitant radiation with chemotherapy if they do not have any measurable lesions outside of the radiation field.
Descrizione

Therapeutic radiology procedure with Chemotherapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0392920
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.
Descrizione

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

Tipo di dati

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
participants who are pregnant or nursing.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participants who are allergic to platinum agents.
Descrizione

Hypersensitivity Pharmaceutical Preparations Platinum-Based

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1514162
participants who receive chemotherapy before that includes cisplatin, carboplatin or oxaliplatin.
Descrizione

Chemotherapy Including Cisplatin | Chemotherapy Including Carboplatin | Chemotherapy Including Oxaliplatin

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C0008838
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332257
UMLS CUI [2,3]
C0079083
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332257
UMLS CUI [3,3]
C0069717
Ritorna all'inizio della pagina

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01261299

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Imaging study | Transitional cell carcinoma of bladder Imaging study | Biopsy Obtain Tissue specimen | Resection Obtain Tissue specimen | Platinum-based chemotherapy Planned | Neoadjuvant Chemotherapy Carcinoma of bladder TNM clinical staging | Palliative therapy Carcinoma of lung TNM clinical staging | Palliative therapy Carcinoma of bladder TNM clinical staging | Platinum-based chemotherapy Transitional cell carcinoma of bladder TNM clinical staging | Platinum-based chemotherapy Non-Small Cell Lung Carcinoma TNM clinical staging | Carcinoma of lung TNM clinical staging Measurable lesion | Carcinoma of bladder TNM clinical staging Measurable lesion
Item
participants must have clinical diagnosis of lung or bladder cancer. the term "clinical diagnosis" means that patients are diagnosed with nsclc or bladder transitional cell carcinoma (tcc) based on imaging studies, but will need further biopsy/resection to obtain tissue in order to confirm the diagnosis. however, some patients may not have cancer as determined by pathology examination of the tissue, or may have a different cancer after biopsy/resection is performed. if the diagnosis of nsclc or bladder cancer is confirmed, platinum-based chemotherapy must be planned either for neoadjuvant chemotherapy for stage ii or above bladder cancer, or palliative therapy for stage iii or iv lung or bladder cancer regardless of patient participation in this study. stage ii or above tcc patients and stage iv nsclc patients that will receive platinum-based chemotherapy will be eligible for this study. patients with stage iii or iv lung or bladder cancer must have measurable lesion(s).
boolean
C0007131 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
C0279680 (UMLS CUI [2,1])
C1881134 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C1301820 (UMLS CUI [3,2])
C1292533 (UMLS CUI [3,3])
C0728940 (UMLS CUI [4,1])
C1301820 (UMLS CUI [4,2])
C1292533 (UMLS CUI [4,3])
C3536920 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0600558 (UMLS CUI [6,1])
C3665472 (UMLS CUI [6,2])
C0699885 (UMLS CUI [6,3])
C3258246 (UMLS CUI [6,4])
C0030231 (UMLS CUI [7,1])
C0684249 (UMLS CUI [7,2])
C3258246 (UMLS CUI [7,3])
C0030231 (UMLS CUI [8,1])
C0699885 (UMLS CUI [8,2])
C3258246 (UMLS CUI [8,3])
C3536920 (UMLS CUI [9,1])
C0279680 (UMLS CUI [9,2])
C3258246 (UMLS CUI [9,3])
C3536920 (UMLS CUI [10,1])
C0007131 (UMLS CUI [10,2])
C3258246 (UMLS CUI [10,3])
C0684249 (UMLS CUI [11,1])
C3258246 (UMLS CUI [11,2])
C1513041 (UMLS CUI [11,3])
C0699885 (UMLS CUI [12,1])
C3258246 (UMLS CUI [12,2])
C1513041 (UMLS CUI [12,3])
Prior radiation therapy Completed | Prior surgery Completed | Measurable lesion Quantity Evaluation | Exception Lesion Radiation Field
Item
prior radiation or surgery is allowed, but should be finished at least 2 weeks prior to study enrollment. if a participant has prior radiation therapy, at least one measurable lesion outside of the radiation field should be available for the evaluation of response to chemotherapy.
boolean
C0279134 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0455610 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0220825 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0221198 (UMLS CUI [4,2])
C1882536 (UMLS CUI [4,3])
Age
Item
participants must be 18 years or older. we do not see any patients with nsclc or bladder tcc are diagnosed under the age of 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status equal or less than to 2 (karnofsky equal to or greater than 50%).
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
participants must have normal organ and marrow function as defined below: absolute neutrophil count greater than/equal to 1,500/microl; platelet count greater than/equal to 100,000/microl; total bilirubin less than 1.5 x uln; ast (sgot) less than/equal to 2.5 x uln; creatinine less than 1.5 x uln
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Informed Consent
Item
ability to understand and willing to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure with Chemotherapy
Item
patients must not receive concomitant radiation with chemotherapy if they do not have any measurable lesions outside of the radiation field.
boolean
C1522449 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
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])
Pregnancy | Breast Feeding
Item
participants who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Pharmaceutical Preparations Platinum-Based
Item
participants who are allergic to platinum agents.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1514162 (UMLS CUI [1,3])
Chemotherapy Including Cisplatin | Chemotherapy Including Carboplatin | Chemotherapy Including Oxaliplatin
Item
participants who receive chemotherapy before that includes cisplatin, carboplatin or oxaliplatin.
boolean
C0392920 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0008838 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C0079083 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0332257 (UMLS CUI [3,2])
C0069717 (UMLS CUI [3,3])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial