ID

38612

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01261299

Stichworte

Versionen (1)
  1. 28.10.19 28.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. Oktober 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01261299

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT01261299

1 Formulare  
Inclusion Criteria
Beschreibung

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status | Karnofsky Performance Status

Datentyp

boolean

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

Life Expectancy

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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.
Beschreibung

Therapeutic radiology procedure with Chemotherapy

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Hypersensitivity Pharmaceutical Preparations Platinum-Based

Datentyp

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.
Beschreibung

Chemotherapy Including Cisplatin | Chemotherapy Including Carboplatin | Chemotherapy Including Oxaliplatin

Datentyp

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
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT01261299

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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