ID

30554

Descripción

Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01004510

Link

https://clinicaltrials.gov/show/NCT01004510

Palabras clave

Versiones (2)
  1. 14/6/18 14/6/18 -
  2. 14/6/18 14/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Malignant Pleural Effusion NCT01004510

Inglés

Eligibility Malignant Pleural Effusion NCT01004510

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented non-small cell lung cancer, stages 3b, 4 or recurrent
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0278517
pleural effusion cytologically proven to be malignant
Descripción

Pleural Effusion, Malignant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0080032
0 or 1 prior chemotherapy regimens for non-small cell lung cancer (adjuvant chemotherapy post resection, or concurrent chemo-radiation therapy counts as one regimen regardless of number of agents used.)
Descripción

Prior Chemotherapy Quantity Non-Small Cell Lung Carcinoma | Adjuvant Chemotherapy Post Excision | Chemoradiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0007131
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0728940
UMLS CUI [3]
C0436307
planning to start chemotherapy for non-small cell lung cancer (treatment regimen at discretion of treating physician but must include one or more of the following agents:cisplatin,carboplatin,docetaxel,paclitaxel, pemetrexed,gemcitabine,vinorelbine) patients may receive anti-angiogenesis agents (bevacizumab) in addition to chemotherapy, but patients treated solely with tyrosine kinase inhibitors or growth-factor receptor blockers are not eligible.
Descripción

Chemotherapy Planned Non-Small Cell Lung Carcinoma | Cisplatin | Carboplatin | docetaxel | Paclitaxel | pemetrexed | gemcitabine | vinorelbine | Angiogenesis Inhibitors | bevacizumab | Tyrosine Kinase Inhibitors Excluded | Growth Factor Receptor Inhibitors Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0007131
UMLS CUI [2]
C0008838
UMLS CUI [3]
C0079083
UMLS CUI [4]
C0246415
UMLS CUI [5]
C0144576
UMLS CUI [6]
C0210657
UMLS CUI [7]
C0045093
UMLS CUI [8]
C0078257
UMLS CUI [9]
C0596087
UMLS CUI [10]
C0796392
UMLS CUI [11,1]
C2757011
UMLS CUI [11,2]
C0332196
UMLS CUI [12,1]
C0206454
UMLS CUI [12,2]
C0243077
UMLS CUI [12,3]
C0332196
prior radiation therapy is permitted.
Descripción

Prior radiation therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279134
performance status 0,1,2
Descripción

Performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518965
serum creatinine less than 2.0 or estimated creatinine clearance over 30cc/min by calcroft/gault equation
Descripción

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
estimated life expectancy over 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
signed informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
age greater than 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients who have clinical indication for zometa treatment such as lytic bone metastases or hypercalcemia can be included
Descripción

Indication Zometa | Secondary malignant neoplasm of bone Osteolytic | Hypercalcemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0939788
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C0302846
UMLS CUI [3]
C0020437
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
Descripción

Comorbidity Preventing Protocol Compliance | Mental disorders Preventing Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
patients who undergo any procedure other than thoracentesis for drainage of effusion.patients may have had more than one thoracentesis prior to study. patients who have large bore chest tube placement, permanent transthoracic catheter (pleurex), medical pleurodesis or thoracoscopy are excluded.
Descripción

Procedure Any | Exception Thoracentesis Drainage Effusion | Thoracentesis Quantity allowed | Chest tube placement | Catheter Transthoracic Permanent | Pleurodesis | Thoracoscopy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0189477
UMLS CUI [2,3]
C0013103
UMLS CUI [2,4]
C0013687
UMLS CUI [3,1]
C0189477
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0683607
UMLS CUI [4]
C0742344
UMLS CUI [5,1]
C0085590
UMLS CUI [5,2]
C4049694
UMLS CUI [5,3]
C0205355
UMLS CUI [6]
C0189557
UMLS CUI [7]
C0039989
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular);dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
Descripción

Tooth problem | Infection of tooth | Maxilla infection | Infection Mandible | Dental trauma | Trauma Fixture dental | Necrosis of bone of jaw | Exposed bone of oral vestibule | Healing Slow Post Dental Procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0576962
UMLS CUI [2]
C0877046
UMLS CUI [3]
C1400602
UMLS CUI [4,1]
C3714514
UMLS CUI [4,2]
C0024687
UMLS CUI [5]
C1301685
UMLS CUI [6,1]
C3714660
UMLS CUI [6,2]
C3879289
UMLS CUI [7]
C2711248
UMLS CUI [8]
C2013525
UMLS CUI [9,1]
C0043240
UMLS CUI [9,2]
C0439834
UMLS CUI [9,3]
C0687676
UMLS CUI [9,4]
C0011331
recent (within 6 weeks)or planned dental or jaw surgery (e.g.extraction, implants).
Descripción

Dental surgical procedure | Jaw Surgery | Dental surgical procedure Planned | Jaw Surgery Planned | Tooth Extraction | Jaw Extraction | Dental Implant | Jaw implant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0204324
UMLS CUI [2]
C0407713
UMLS CUI [3,1]
C0204324
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0407713
UMLS CUI [4,2]
C1301732
UMLS CUI [5]
C0040440
UMLS CUI [6,1]
C0022359
UMLS CUI [6,2]
C0185115
UMLS CUI [7]
C0011370
UMLS CUI [8]
C0441366
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Similar models

Eligibility Malignant Pleural Effusion NCT01004510

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent
Item
histologically documented non-small cell lung cancer, stages 3b, 4 or recurrent
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2])
Pleural Effusion, Malignant
Item
pleural effusion cytologically proven to be malignant
boolean
C0080032 (UMLS CUI [1])
Prior Chemotherapy Quantity Non-Small Cell Lung Carcinoma | Adjuvant Chemotherapy Post Excision | Chemoradiotherapy
Item
0 or 1 prior chemotherapy regimens for non-small cell lung cancer (adjuvant chemotherapy post resection, or concurrent chemo-radiation therapy counts as one regimen regardless of number of agents used.)
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C0436307 (UMLS CUI [3])
Chemotherapy Planned Non-Small Cell Lung Carcinoma | Cisplatin | Carboplatin | docetaxel | Paclitaxel | pemetrexed | gemcitabine | vinorelbine | Angiogenesis Inhibitors | bevacizumab | Tyrosine Kinase Inhibitors Excluded | Growth Factor Receptor Inhibitors Excluded
Item
planning to start chemotherapy for non-small cell lung cancer (treatment regimen at discretion of treating physician but must include one or more of the following agents:cisplatin,carboplatin,docetaxel,paclitaxel, pemetrexed,gemcitabine,vinorelbine) patients may receive anti-angiogenesis agents (bevacizumab) in addition to chemotherapy, but patients treated solely with tyrosine kinase inhibitors or growth-factor receptor blockers are not eligible.
boolean
C0392920 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C0008838 (UMLS CUI [2])
C0079083 (UMLS CUI [3])
C0246415 (UMLS CUI [4])
C0144576 (UMLS CUI [5])
C0210657 (UMLS CUI [6])
C0045093 (UMLS CUI [7])
C0078257 (UMLS CUI [8])
C0596087 (UMLS CUI [9])
C0796392 (UMLS CUI [10])
C2757011 (UMLS CUI [11,1])
C0332196 (UMLS CUI [11,2])
C0206454 (UMLS CUI [12,1])
C0243077 (UMLS CUI [12,2])
C0332196 (UMLS CUI [12,3])
Prior radiation therapy
Item
prior radiation therapy is permitted.
boolean
C0279134 (UMLS CUI [1])
Performance status
Item
performance status 0,1,2
boolean
C1518965 (UMLS CUI [1])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
serum creatinine less than 2.0 or estimated creatinine clearance over 30cc/min by calcroft/gault equation
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Life Expectancy
Item
estimated life expectancy over 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age greater than 18 years
boolean
C0001779 (UMLS CUI [1])
Indication Zometa | Secondary malignant neoplasm of bone Osteolytic | Hypercalcemia
Item
patients who have clinical indication for zometa treatment such as lytic bone metastases or hypercalcemia can be included
boolean
C3146298 (UMLS CUI [1,1])
C0939788 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C0302846 (UMLS CUI [2,2])
C0020437 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Preventing Protocol Compliance | Mental disorders Preventing Protocol Compliance
Item
patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
boolean
C0009488 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Procedure Any | Exception Thoracentesis Drainage Effusion | Thoracentesis Quantity allowed | Chest tube placement | Catheter Transthoracic Permanent | Pleurodesis | Thoracoscopy
Item
patients who undergo any procedure other than thoracentesis for drainage of effusion.patients may have had more than one thoracentesis prior to study. patients who have large bore chest tube placement, permanent transthoracic catheter (pleurex), medical pleurodesis or thoracoscopy are excluded.
boolean
C0184661 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0189477 (UMLS CUI [2,2])
C0013103 (UMLS CUI [2,3])
C0013687 (UMLS CUI [2,4])
C0189477 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0742344 (UMLS CUI [4])
C0085590 (UMLS CUI [5,1])
C4049694 (UMLS CUI [5,2])
C0205355 (UMLS CUI [5,3])
C0189557 (UMLS CUI [6])
C0039989 (UMLS CUI [7])
Tooth problem | Infection of tooth | Maxilla infection | Infection Mandible | Dental trauma | Trauma Fixture dental | Necrosis of bone of jaw | Exposed bone of oral vestibule | Healing Slow Post Dental Procedure
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular);dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400602 (UMLS CUI [3])
C3714514 (UMLS CUI [4,1])
C0024687 (UMLS CUI [4,2])
C1301685 (UMLS CUI [5])
C3714660 (UMLS CUI [6,1])
C3879289 (UMLS CUI [6,2])
C2711248 (UMLS CUI [7])
C2013525 (UMLS CUI [8])
C0043240 (UMLS CUI [9,1])
C0439834 (UMLS CUI [9,2])
C0687676 (UMLS CUI [9,3])
C0011331 (UMLS CUI [9,4])
Dental surgical procedure | Jaw Surgery | Dental surgical procedure Planned | Jaw Surgery Planned | Tooth Extraction | Jaw Extraction | Dental Implant | Jaw implant
Item
recent (within 6 weeks)or planned dental or jaw surgery (e.g.extraction, implants).
boolean
C0204324 (UMLS CUI [1])
C0407713 (UMLS CUI [2])
C0204324 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0407713 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0040440 (UMLS CUI [5])
C0022359 (UMLS CUI [6,1])
C0185115 (UMLS CUI [6,2])
C0011370 (UMLS CUI [7])
C0441366 (UMLS CUI [8])
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