ID

27237

Descripción

Genexol-PM Versus Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01169870

Link

https://clinicaltrials.gov/show/NCT01169870

Palabras clave

Versiones (1)
  1. 3/11/17 3/11/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de noviembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01169870

Inglés

Eligibility Breast Cancer NCT01169870

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically diagnosed stage iv or recurrent breast cancer patients according to american joint committee on cancer (ajcc 6th ed.)
Descripción

Secondary malignant neoplasm of female breast | Breast cancer recurrent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C0278493
2. prior chemotherapy at least one anthracycline-containing regimen, in either adjuvant or metastatic setting is requested.
Descripción

Chemotherapy, Adjuvant | Chemotherapy Secondary malignant neoplasm of female breast | Anthracyclines

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0346993
UMLS CUI [3]
C0282564
3. previous hormonal therapy in adjuvant setting is allowed.
Descripción

Hormone Therapy Adjuvant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
4. previous adjuvant taxane chemotherapy in an adjuvant setting is allowed, if taxane-free interval is more than 12 months
Descripción

Chemotherapy, Adjuvant | Taxane

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2]
C0215136
5. previous chemotherapy for metastatic disease is not allowed except for the regimen including anthracycline.
Descripción

Exclusion | Chemotherapy Neoplasm Metastasis | Exception Anthracyclines

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0027627
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0282564
6. previous chemotherapy including taxane for metastatic disease is not allowed.
Descripción

Exclusion Criteria | Chemotherapy Neoplasm Metastasis | Taxane

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0027627
UMLS CUI [3]
C0215136
7. prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
Descripción

Therapeutic radiology procedure | Measurable Disease Area multiple

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0205146
UMLS CUI [2,3]
C0439064
8. no other forms of cancer therapy, such as radiation, immunotherapy or chemotherapy for at least 4 weeks before the enrollment in therapy.
Descripción

Cancer treatment Other Absent | Therapeutic radiology procedure | Immunotherapy | Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0392920
9. major surgery other than biopsy within the past two weeks.
Descripción

Major surgery | Exception Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
10. at least 18 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
11. performance status of 0, 1 and 2 on the ecog criteria.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
12. disease status must be that of measurable disease defined as recist:
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
lesions that can be accurately measured in at least one dimension > 10 mm with chest x-ray, spiral ct scan, mri, or physical examination
Descripción

Measurable lesion Dimensions Quantity Chest X-ray | Measurable lesion Dimensions Quantity Spiral CT scan | Measurable lesion Dimensions Quantity MRI | Measurable lesion Dimensions Quantity Physical Examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0439534
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0039985
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0860888
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0439534
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0024485
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0439534
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0031809
13. estimated life expectancy of at least 12 weeks.
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
14. patient compliance that allow adequate follow-up.
Descripción

Compliance behavior allowing Follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C3274571
15. adequate major organ function including the following:
Descripción

Organ Major Function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0031843
①hematologic function: wbc ³ 3,000/mm3 or absolute neutrophil count (anc) ³
Descripción

Hematologic function | White Blood Cell Count procedure | Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
1,500/mm3, platelet count ³ 100,000/mm3
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
②hepatic function: bilirubin 1.5 x unl , ast/alt levels 2.5 x unl
Descripción

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
③renal function: serum creatinine 1.5mg/dl
Descripción

Renal function | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
16. grade of baseline neuropathy should not be more than grade 1 by nci ctc v.3.0
Descripción

Neuropathy CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
17. patients should sign an informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
18. women of childbearing age should use non-hormonal contraceptive method.
Descripción

Childbearing Potential Contraceptive methods | Exception Hormonal contraception

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2985296
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
Descripción

Communicable Disease Serious Uncontrolled | Illness Serious Uncontrolled | Communicable Disease Serious Control At risk | Illness Serious Control At risk

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0243148
UMLS CUI [3,4]
C1444641
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0243148
UMLS CUI [4,4]
C1444641
2. other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
Descripción

Cancer Other | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
3. psychiatric disorder that would preclude compliance.
Descripción

Mental disorder Excludes Compliance behavior

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1321605
4. uncontrolled cns disease (eligible if the cns disease is controlled with radiotherapy or corticosteroid)
Descripción

CNS disorder Uncontrolled | Eligible Therapeutic radiology procedure CNS disorder | Eligible Adrenal Cortex Hormones CNS disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0007682
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C0007682
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Similar models

Eligibility Breast Cancer NCT01169870

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast | Breast cancer recurrent
Item
1. histologically or cytologically diagnosed stage iv or recurrent breast cancer patients according to american joint committee on cancer (ajcc 6th ed.)
boolean
C0346993 (UMLS CUI [1])
C0278493 (UMLS CUI [2])
Chemotherapy, Adjuvant | Chemotherapy Secondary malignant neoplasm of female breast | Anthracyclines
Item
2. prior chemotherapy at least one anthracycline-containing regimen, in either adjuvant or metastatic setting is requested.
boolean
C0085533 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C0282564 (UMLS CUI [3])
Hormone Therapy Adjuvant
Item
3. previous hormonal therapy in adjuvant setting is allowed.
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
Chemotherapy, Adjuvant | Taxane
Item
4. previous adjuvant taxane chemotherapy in an adjuvant setting is allowed, if taxane-free interval is more than 12 months
boolean
C0085533 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
Exclusion | Chemotherapy Neoplasm Metastasis | Exception Anthracyclines
Item
5. previous chemotherapy for metastatic disease is not allowed except for the regimen including anthracycline.
boolean
C2828389 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0282564 (UMLS CUI [3,2])
Exclusion Criteria | Chemotherapy Neoplasm Metastasis | Taxane
Item
6. previous chemotherapy including taxane for metastatic disease is not allowed.
boolean
C0680251 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C0215136 (UMLS CUI [3])
Therapeutic radiology procedure | Measurable Disease Area multiple
Item
7. prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
boolean
C1522449 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
Cancer treatment Other Absent | Therapeutic radiology procedure | Immunotherapy | Chemotherapy
Item
8. no other forms of cancer therapy, such as radiation, immunotherapy or chemotherapy for at least 4 weeks before the enrollment in therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Major surgery | Exception Biopsy
Item
9. major surgery other than biopsy within the past two weeks.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Age
Item
10. at least 18 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
11. performance status of 0, 1 and 2 on the ecog criteria.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
12. disease status must be that of measurable disease defined as recist:
boolean
C1513041 (UMLS CUI [1])
Measurable lesion Dimensions Quantity Chest X-ray | Measurable lesion Dimensions Quantity Spiral CT scan | Measurable lesion Dimensions Quantity MRI | Measurable lesion Dimensions Quantity Physical Examination
Item
lesions that can be accurately measured in at least one dimension > 10 mm with chest x-ray, spiral ct scan, mri, or physical examination
boolean
C1513041 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0039985 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0860888 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
C1513041 (UMLS CUI [4,1])
C0439534 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0031809 (UMLS CUI [4,4])
Life Expectancy
Item
13. estimated life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Compliance behavior allowing Follow-up
Item
14. patient compliance that allow adequate follow-up.
boolean
C1321605 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Organ Major Function
Item
15. adequate major organ function including the following:
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
Hematologic function | White Blood Cell Count procedure | Absolute neutrophil count
Item
①hematologic function: wbc ³ 3,000/mm3 or absolute neutrophil count (anc) ³
boolean
C0221130 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
Platelet Count measurement
Item
1,500/mm3, platelet count ³ 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
②hepatic function: bilirubin 1.5 x unl , ast/alt levels 2.5 x unl
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
③renal function: serum creatinine 1.5mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Neuropathy CTCAE Grades
Item
16. grade of baseline neuropathy should not be more than grade 1 by nci ctc v.3.0
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Informed Consent
Item
17. patients should sign an informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Exception Hormonal contraception
Item
18. women of childbearing age should use non-hormonal contraceptive method.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2985296 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Serious Uncontrolled | Illness Serious Uncontrolled | Communicable Disease Serious Control At risk | Illness Serious Control At risk
Item
1. serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0243148 (UMLS CUI [3,3])
C1444641 (UMLS CUI [3,4])
C0221423 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0243148 (UMLS CUI [4,3])
C1444641 (UMLS CUI [4,4])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
2. other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Mental disorder Excludes Compliance behavior
Item
3. psychiatric disorder that would preclude compliance.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
CNS disorder Uncontrolled | Eligible Therapeutic radiology procedure CNS disorder | Eligible Adrenal Cortex Hormones CNS disorder
Item
4. uncontrolled cns disease (eligible if the cns disease is controlled with radiotherapy or corticosteroid)
boolean
C0007682 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0007682 (UMLS CUI [2,3])
C1548635 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0007682 (UMLS CUI [3,3])
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