ID

18494

Descrizione

Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00378404

collegamento

https://clinicaltrials.gov/show/NCT00378404

Keywords

  1. 08/11/16 08/11/16 -
Caricato su

8 novembre 2016

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Non-Small Cell Lung Cancer NCT00378404

Eligibility Non-Small Cell Lung Cancer NCT00378404

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be 18 years of age or greater.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically proven non-small cell lung cancer that is either metastatic or recurrent and failed at least one prior platinum-based chemotherapeutic regimen.
Descrizione

Non-small cell lung cancer metastatic | Non-small cell lung cancer recurrent | Prior Chemotherapy Platinum-Based Quantity failed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0278987
UMLS CUI [2]
C0278517
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C1514162
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0231175
patients who have recurred after previous surgery and/or radiation may participate in this trial.
Descrizione

Operative Surgical Procedures | prior radiation therapy | Recurrence

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0279134
UMLS CUI [3]
C2825055
patients may have had prior neoadjuvant or adjuvant therapy.
Descrizione

Neoadjuvant Therapy | Adjuvant therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2]
C0677850
patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable and documented by a stable or improved pretreatment ct or mri scan of the brain to evaluate for cns disease within 28 days prior to registration.
Descrizione

Metastatic malignant neoplasm to brain | Disease Treated | Pretreatment Stable status Brain | X-Ray Computed Tomography | Magnetic Resonance Imaging | Evaluation CNS disorder

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C3539076
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C0006104
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
UMLS CUI [6,1]
C1261322
UMLS CUI [6,2]
C0007682
measurable or non-measurable disease documented by ct, mri, x-ray or nuclear exam (fdg-pet). measurable or non-measurable disease must be present outside the area of surgical resection. pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease.
Descrizione

Measurable Disease | Non-Measurable Lesion | X-Ray Computed Tomography | Magnetic Resonance Imaging | FDG-Positron Emission Tomography | Excision | Pleural effusion | Ascites | Laboratory Results

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0024485
UMLS CUI [5]
C3641247
UMLS CUI [6]
C0728940
UMLS CUI [7]
C0032227
UMLS CUI [8]
C0003962
UMLS CUI [9]
C1254595
progression after at least one prior platinum-based chemotherapy.
Descrizione

Prior Chemotherapy Platinum-Based Quantity | Disease Progression

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0242656
greater than 3 weeks since surgery and must have recovered from all associated toxicities at time of registration.
Descrizione

Operative Surgical Procedure | Toxic effect Recovered

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0521108
anc ≥ 1,500/µl and platelet count ≥ 100,000/µl obtained within 28 days prior to registration.
Descrizione

Absolute neutrophil count | Platelet Count measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
adequate hepatic function documented by a serum bilirubin ≤ 1.5 times institutional upper limit of normal and liver enzymes (sgot or sgpt) ≤ 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration.
Descrizione

Liver function | Serum total bilirubin measurement | Measurement of liver enzyme | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0428321
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
patients requiring lung radiation must have an fev1 of > 1000 liters obtained within 28 days prior to registration and must have pulmonary function tests with dlco.
Descrizione

Radiotherapy to lung Patient need for | FEV1 | Pulmonary function tests | Carbon Monoxide Diffusing Capability Test

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0948315
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C0748133
UMLS CUI [3]
C0024119
UMLS CUI [4]
C1516251
zubrod performance status of 0,1 or 2.
Descrizione

Zubrod Performance Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3714786
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
no prior single-agent, weekly docetaxel chemotherapy.
Descrizione

docetaxel Single agent Chemotherapy Frequency

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C3846440
UMLS CUI [1,3]
C0376249
peripheral neuropathy ≥ grade 1.
Descrizione

Peripheral Neuropathy | CTCAE Grades

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years.
Descrizione

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Malignant Neoplasm In complete remission | TNM clinical staging | Malignant Neoplasm Disease Free of

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0677874
UMLS CUI [6]
C3258246
UMLS CUI [7,1]
C0006826
UMLS CUI [7,2]
C0012634
UMLS CUI [7,3]
C0332296
pregnant or nursing women.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Non-Small Cell Lung Cancer NCT00378404

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients must be 18 years of age or greater.
boolean
C0001779 (UMLS CUI [1])
Non-small cell lung cancer metastatic | Non-small cell lung cancer recurrent | Prior Chemotherapy Platinum-Based Quantity failed
Item
histologically or cytologically proven non-small cell lung cancer that is either metastatic or recurrent and failed at least one prior platinum-based chemotherapeutic regimen.
boolean
C0278987 (UMLS CUI [1])
C0278517 (UMLS CUI [2])
C1514457 (UMLS CUI [3,1])
C1514162 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0231175 (UMLS CUI [3,4])
Operative Surgical Procedures | prior radiation therapy | Recurrence
Item
patients who have recurred after previous surgery and/or radiation may participate in this trial.
boolean
C0543467 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C2825055 (UMLS CUI [3])
Neoadjuvant Therapy | Adjuvant therapy
Item
patients may have had prior neoadjuvant or adjuvant therapy.
boolean
C0600558 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
Metastatic malignant neoplasm to brain | Disease Treated | Pretreatment Stable status Brain | X-Ray Computed Tomography | Magnetic Resonance Imaging | Evaluation CNS disorder
Item
patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable and documented by a stable or improved pretreatment ct or mri scan of the brain to evaluate for cns disease within 28 days prior to registration.
boolean
C0220650 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C3539076 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0006104 (UMLS CUI [3,3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C1261322 (UMLS CUI [6,1])
C0007682 (UMLS CUI [6,2])
Measurable Disease | Non-Measurable Lesion | X-Ray Computed Tomography | Magnetic Resonance Imaging | FDG-Positron Emission Tomography | Excision | Pleural effusion | Ascites | Laboratory Results
Item
measurable or non-measurable disease documented by ct, mri, x-ray or nuclear exam (fdg-pet). measurable or non-measurable disease must be present outside the area of surgical resection. pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease.
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C3641247 (UMLS CUI [5])
C0728940 (UMLS CUI [6])
C0032227 (UMLS CUI [7])
C0003962 (UMLS CUI [8])
C1254595 (UMLS CUI [9])
Prior Chemotherapy Platinum-Based Quantity | Disease Progression
Item
progression after at least one prior platinum-based chemotherapy.
boolean
C1514457 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
Operative Surgical Procedure | Toxic effect Recovered
Item
greater than 3 weeks since surgery and must have recovered from all associated toxicities at time of registration.
boolean
C0543467 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Absolute neutrophil count | Platelet Count measurement
Item
anc ≥ 1,500/µl and platelet count ≥ 100,000/µl obtained within 28 days prior to registration.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Measurement of liver enzyme | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
adequate hepatic function documented by a serum bilirubin ≤ 1.5 times institutional upper limit of normal and liver enzymes (sgot or sgpt) ≤ 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0428321 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
Radiotherapy to lung Patient need for | FEV1 | Pulmonary function tests | Carbon Monoxide Diffusing Capability Test
Item
patients requiring lung radiation must have an fev1 of > 1000 liters obtained within 28 days prior to registration and must have pulmonary function tests with dlco.
boolean
C0948315 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
C0024119 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
Zubrod Performance Status
Item
zubrod performance status of 0,1 or 2.
boolean
C3714786 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
docetaxel Single agent Chemotherapy Frequency
Item
no prior single-agent, weekly docetaxel chemotherapy.
boolean
C0246415 (UMLS CUI [1,1])
C3846440 (UMLS CUI [1,2])
C0376249 (UMLS CUI [1,3])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy ≥ grade 1.
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Malignant Neoplasm In complete remission | TNM clinical staging | Malignant Neoplasm Disease Free of
Item
prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5,1])
C0677874 (UMLS CUI [5,2])
C3258246 (UMLS CUI [6])
C0006826 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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