ID

18494

Description

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

Link

https://clinicaltrials.gov/show/NCT00378404

Keywords

Versions (1)
  1. 11/8/16 11/8/16 -
Uploaded on

November 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00378404

English

Eligibility Non-Small Cell Lung Cancer NCT00378404

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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.
Description

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

Data type

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.
Description

Operative Surgical Procedures | prior radiation therapy | Recurrence

Data type

boolean

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

Neoadjuvant Therapy | Adjuvant therapy

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

Prior Chemotherapy Platinum-Based Quantity | Disease Progression

Data type

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.
Description

Operative Surgical Procedure | Toxic effect Recovered

Data type

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.
Description

Absolute neutrophil count | Platelet Count measurement

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
Exclusion Criteria
Description

Exclusion Criteria

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

docetaxel Single agent Chemotherapy Frequency

Data type

boolean

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

Peripheral Neuropathy | CTCAE Grades

Data type

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.
Description

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

Data type

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.
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Eligibility Non-Small Cell Lung Cancer NCT00378404

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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