ID

43659

Beschreibung

BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT02283749

Link

https://clinicaltrials.gov/show/NCT02283749

Stichworte

Versionen (2)
  1. 06.06.16 06.06.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer With Bone Metastatses NCT02283749

Englisch

Eligibility Non Small Cell Lung Cancer With Bone Metastatses NCT02283749

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years. advanced non-small cell lung cancer with bone metastases. stable or responding disease after completion of initial systemic chemotherapy as defined by recist criteria. site to submit confirmation to bruog.
Beschreibung

Age | Non-Small Cell Lung Carcinoma Secondary malignant neoplasm of bone Advanced | Stable Disease | Disease Response | Systemic Chemotherapy Initial Complete

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0153690
UMLS CUI [2,3]
C0205179
UMLS CUI [3]
C0677946
UMLS CUI [4]
C1704632
UMLS CUI [5,1]
C1883256
UMLS CUI [5,2]
C0205265
UMLS CUI [5,3]
C0205197
at least 3 weeks must have elapsed since completion of last chemotherapy or radiation prior to first dose of xofigo. patients are not permitted to receive any form of
Beschreibung

Chemotherapy Regimen Complete | Radiation | Xofigo

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0851346
UMLS CUI [3]
C3643595
'maintenance' chemotherapy or biologic/targeted anticancer therapy while being treated on this study life expectancy of at least 12 weeks (3 months). patients with treated brain metastases are allowed, but must have brain imaging showing evidence of stability since most recent treatment for brain mets, prior to first dose of xofigo. scan must be sent to bruog with registration information before patient is registered on study.
Beschreibung

Maintenance Chemotherapy | cancer treatment biological | Targeted cancer therapy | Life Expectancy | Metastatic malignant neoplasm to brain | Imaging of brain | Xofigo

Datentyp

boolean

Alias
UMLS CUI [1]
C0481504
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205460
UMLS CUI [3]
C3854476
UMLS CUI [4]
C0023671
UMLS CUI [5]
C0220650
UMLS CUI [6]
C0203860
UMLS CUI [7]
C3643595
eastern cooperative oncology group (ecog) performance status of 0 - 1. required entry laboratory parameters within 14 days of study entry: white blood cell count (wbc) ≥
Beschreibung

ECOG performance status | Laboratory Finding or Test Result | White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1254360
UMLS CUI [3]
C0023508
3,000/mm3; absolute neutrophil count (anc) ≥ 1,500/mm3; platelet (plt) count ≥
Beschreibung

Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
100,000/mm3; hemoglobin (hgb) > 9g/dl, total bilirubin level ≤ 1.5 x institutional upper limit of normal (uln); aspartate aminotransferase (ast) and alanine aminotransferase (alt)
Beschreibung

Hemoglobin | Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
≤ 2.5 x uln ; creatinine ≤ 1.5 x uln; albumin > 2.5 g/dl.
Beschreibung

Creatinine measurement, serum | Albumin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201838
concurrent treatment with bisphosphonates and denosumab is allowed. information on start and stop date and drug with dose to be sent to bruog if patient to be treated concurrently.
Beschreibung

Therapeutic procedure Diphosphonates | Therapeutic procedure denosumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0012544
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1690432
prior skeletal related events (pathologic fracture, radiation or surgery to bone, or spinal cord compression) are allowed if they have been managed and now patient is stable for 4 weeks prior to study entry. must submit how events managed to bruog for documentation to confirm eligibility criterion. (for example, if a patient experienced a sse and had radiation for 2 weeks they must then be stable for 4 weeks after the completion of radiation prior to study entry) subjects must be able to understand and be willing to sign the written informed consent form.
Beschreibung

Skeletal system Adverse event | Skeletal bone Pathological fracture | Skeletal bone Radiation | Skeletal bone Operative Surgical Procedures | Compression of spinal cord | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037253
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C0016663
UMLS CUI [3,1]
C0262950
UMLS CUI [3,2]
C0851346
UMLS CUI [4,1]
C0262950
UMLS CUI [4,2]
C0543467
UMLS CUI [5]
C0037926
UMLS CUI [6]
C0021430
all acute toxic effects related to prior treatment(s) must have resolved to nci-ctcae v4 grade 1 or less at the time of signing the informed consent form (icf) except for alopecia.
Beschreibung

Toxic effect Due to Prior Therapy | physiologic resolution | Common Terminology Criteria for Adverse Events | Alopecia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2]
C1514893
UMLS CUI [3]
C3888020
UMLS CUI [4]
C1559115
women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
Beschreibung

Childbearing Potential Serum pregnancy test negative | Postmenopausal state | Menstruation Absent | Female Sterilization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0025344
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0015787
subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the icf until at least 30 days after the last dose of study drug. the definition of adequate contraception will be based on the judgment of the treating physician.
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
willing and able to comply with the protocol, including follow-up visits and examinations
Beschreibung

Compliance behavior Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium ra 223 dichloride) for the treatment of bony metastases no prior invasive malignancy within the prior two years. however, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible untreated brain metastases. any other serious illness or medical condition that in the investigator's opinion would interfere with protocol treatment, such as but not limited to: any active infection ≥ national cancer institute common terminology criteria for adverse events (nci-ctcae) version 4 grade 2: cardiac failure new york heart association (nyha) iii or iv women who are pregnant or breast-feeding. inability to comply with the protocol and/or not willing or who will not be available for follow-up assessments.
Beschreibung

systemic therapy Radioisotopes | Strontium-89 | SAMARIUM Sm153 | Rhenium-186 | ^188^Rhenium | radium Ra 223 dichloride | Secondary malignant neoplasm of bone | invasive cancer | Malignant Neoplasms Limited stage | Early-Stage Breast Carcinoma | Prostate carcinoma Asymptomatic | Metastatic malignant neoplasm to brain | Disease Interferes with Study Protocol | Communicable Diseases | New York Heart Association Classification | Pregnancy | Breast Feeding | Compliance behavior Limited Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0034595
UMLS CUI [2]
C0281385
UMLS CUI [3]
C0677942
UMLS CUI [4]
C0361302
UMLS CUI [5]
C1828331
UMLS CUI [6]
C3541342
UMLS CUI [7]
C0153690
UMLS CUI [8]
C0677898
UMLS CUI [9,1]
C0006826
UMLS CUI [9,2]
C1517886
UMLS CUI [10]
C2986665
UMLS CUI [11,1]
C0600139
UMLS CUI [11,2]
C0231221
UMLS CUI [12]
C0220650
UMLS CUI [13,1]
C0012634
UMLS CUI [13,2]
C0521102
UMLS CUI [13,3]
C2348563
UMLS CUI [14]
C0009450
UMLS CUI [15]
C1275491
UMLS CUI [16]
C0032961
UMLS CUI [17]
C0006147
UMLS CUI [18,1]
C1321605
UMLS CUI [18,2]
C0439801
UMLS CUI [18,3]
C2348563
any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Beschreibung

medical condition Study Subject Participation Status Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than ra 223 dichloride.
Beschreibung

cancer treatment Concurrent | Chemotherapy Regimen | Therapeutic radiology procedure | Operative Surgical Procedures | Immunotherapy | Biological Response Modifier Therapy | transcatheter embolization for tumor destruction | radium Ra 223 dichloride

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0543467
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0005527
UMLS CUI [7]
C2069648
UMLS CUI [8]
C3541342
major surgery within 28 days of starting study drug. central venous catheter placement is not considered major surgery.
Beschreibung

major surgery | Insertion of central venous catheter

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3521108
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Ähnliche Modelle

Eligibility Non Small Cell Lung Cancer With Bone Metastatses NCT02283749

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Non-Small Cell Lung Carcinoma Secondary malignant neoplasm of bone Advanced | Stable Disease | Disease Response | Systemic Chemotherapy Initial Complete
Item
age ≥ 18 years. advanced non-small cell lung cancer with bone metastases. stable or responding disease after completion of initial systemic chemotherapy as defined by recist criteria. site to submit confirmation to bruog.
boolean
C0001779 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C0677946 (UMLS CUI [3])
C1704632 (UMLS CUI [4])
C1883256 (UMLS CUI [5,1])
C0205265 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
Chemotherapy Regimen Complete | Radiation | Xofigo
Item
at least 3 weeks must have elapsed since completion of last chemotherapy or radiation prior to first dose of xofigo. patients are not permitted to receive any form of
boolean
C0392920 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0851346 (UMLS CUI [2])
C3643595 (UMLS CUI [3])
Maintenance Chemotherapy | cancer treatment biological | Targeted cancer therapy | Life Expectancy | Metastatic malignant neoplasm to brain | Imaging of brain | Xofigo
Item
'maintenance' chemotherapy or biologic/targeted anticancer therapy while being treated on this study life expectancy of at least 12 weeks (3 months). patients with treated brain metastases are allowed, but must have brain imaging showing evidence of stability since most recent treatment for brain mets, prior to first dose of xofigo. scan must be sent to bruog with registration information before patient is registered on study.
boolean
C0481504 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
C3854476 (UMLS CUI [3])
C0023671 (UMLS CUI [4])
C0220650 (UMLS CUI [5])
C0203860 (UMLS CUI [6])
C3643595 (UMLS CUI [7])
ECOG performance status | Laboratory Finding or Test Result | White Blood Cell Count procedure
Item
eastern cooperative oncology group (ecog) performance status of 0 - 1. required entry laboratory parameters within 14 days of study entry: white blood cell count (wbc) ≥
boolean
C1520224 (UMLS CUI [1])
C1254360 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement
Item
3,000/mm3; absolute neutrophil count (anc) ≥ 1,500/mm3; platelet (plt) count ≥
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Hemoglobin | Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
100,000/mm3; hemoglobin (hgb) > 9g/dl, total bilirubin level ≤ 1.5 x institutional upper limit of normal (uln); aspartate aminotransferase (ast) and alanine aminotransferase (alt)
boolean
C0019046 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Creatinine measurement, serum | Albumin measurement
Item
≤ 2.5 x uln ; creatinine ≤ 1.5 x uln; albumin > 2.5 g/dl.
boolean
C0201976 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
Therapeutic procedure Diphosphonates | Therapeutic procedure denosumab
Item
concurrent treatment with bisphosphonates and denosumab is allowed. information on start and stop date and drug with dose to be sent to bruog if patient to be treated concurrently.
boolean
C0087111 (UMLS CUI [1,1])
C0012544 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1690432 (UMLS CUI [2,2])
Skeletal system Adverse event | Skeletal bone Pathological fracture | Skeletal bone Radiation | Skeletal bone Operative Surgical Procedures | Compression of spinal cord | Informed Consent
Item
prior skeletal related events (pathologic fracture, radiation or surgery to bone, or spinal cord compression) are allowed if they have been managed and now patient is stable for 4 weeks prior to study entry. must submit how events managed to bruog for documentation to confirm eligibility criterion. (for example, if a patient experienced a sse and had radiation for 2 weeks they must then be stable for 4 weeks after the completion of radiation prior to study entry) subjects must be able to understand and be willing to sign the written informed consent form.
boolean
C0037253 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0262950 (UMLS CUI [2,1])
C0016663 (UMLS CUI [2,2])
C0262950 (UMLS CUI [3,1])
C0851346 (UMLS CUI [3,2])
C0262950 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0037926 (UMLS CUI [5])
C0021430 (UMLS CUI [6])
Toxic effect Due to Prior Therapy | physiologic resolution | Common Terminology Criteria for Adverse Events | Alopecia
Item
all acute toxic effects related to prior treatment(s) must have resolved to nci-ctcae v4 grade 1 or less at the time of signing the informed consent form (icf) except for alopecia.
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1514893 (UMLS CUI [2])
C3888020 (UMLS CUI [3])
C1559115 (UMLS CUI [4])
Childbearing Potential Serum pregnancy test negative | Postmenopausal state | Menstruation Absent | Female Sterilization
Item
women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0025344 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the icf until at least 30 days after the last dose of study drug. the definition of adequate contraception will be based on the judgment of the treating physician.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Compliance behavior Study Protocol
Item
willing and able to comply with the protocol, including follow-up visits and examinations
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
systemic therapy Radioisotopes | Strontium-89 | SAMARIUM Sm153 | Rhenium-186 | ^188^Rhenium | radium Ra 223 dichloride | Secondary malignant neoplasm of bone | invasive cancer | Malignant Neoplasms Limited stage | Early-Stage Breast Carcinoma | Prostate carcinoma Asymptomatic | Metastatic malignant neoplasm to brain | Disease Interferes with Study Protocol | Communicable Diseases | New York Heart Association Classification | Pregnancy | Breast Feeding | Compliance behavior Limited Study Protocol
Item
received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium ra 223 dichloride) for the treatment of bony metastases no prior invasive malignancy within the prior two years. however, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible untreated brain metastases. any other serious illness or medical condition that in the investigator's opinion would interfere with protocol treatment, such as but not limited to: any active infection ≥ national cancer institute common terminology criteria for adverse events (nci-ctcae) version 4 grade 2: cardiac failure new york heart association (nyha) iii or iv women who are pregnant or breast-feeding. inability to comply with the protocol and/or not willing or who will not be available for follow-up assessments.
boolean
C1515119 (UMLS CUI [1,1])
C0034595 (UMLS CUI [1,2])
C0281385 (UMLS CUI [2])
C0677942 (UMLS CUI [3])
C0361302 (UMLS CUI [4])
C1828331 (UMLS CUI [5])
C3541342 (UMLS CUI [6])
C0153690 (UMLS CUI [7])
C0677898 (UMLS CUI [8])
C0006826 (UMLS CUI [9,1])
C1517886 (UMLS CUI [9,2])
C2986665 (UMLS CUI [10])
C0600139 (UMLS CUI [11,1])
C0231221 (UMLS CUI [11,2])
C0220650 (UMLS CUI [12])
C0012634 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C2348563 (UMLS CUI [13,3])
C0009450 (UMLS CUI [14])
C1275491 (UMLS CUI [15])
C0032961 (UMLS CUI [16])
C0006147 (UMLS CUI [17])
C1321605 (UMLS CUI [18,1])
C0439801 (UMLS CUI [18,2])
C2348563 (UMLS CUI [18,3])
medical condition Study Subject Participation Status Limited
Item
any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
boolean
C1699700 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
cancer treatment Concurrent | Chemotherapy Regimen | Therapeutic radiology procedure | Operative Surgical Procedures | Immunotherapy | Biological Response Modifier Therapy | transcatheter embolization for tumor destruction | radium Ra 223 dichloride
Item
concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than ra 223 dichloride.
boolean
C0920425 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0005527 (UMLS CUI [6])
C2069648 (UMLS CUI [7])
C3541342 (UMLS CUI [8])
major surgery | Insertion of central venous catheter
Item
major surgery within 28 days of starting study drug. central venous catheter placement is not considered major surgery.
boolean
C0679637 (UMLS CUI [1])
C3521108 (UMLS CUI [2])
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