ID

16328

Beskrivning

Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow; ODM derived from: https://clinicaltrials.gov/show/NCT00248703

Länk

https://clinicaltrials.gov/show/NCT00248703

Nyckelord

Versioner (1)
  1. 2016-07-11 2016-07-11 -
Uppladdad den

11 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00248703

Engelsk

Eligibility Breast Cancer NCT00248703

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. breast cancer with node positive disease or high risk node negative disease (pt1c/t2gii-iiin0, pt3n0, ct3n0). patients < 35 years with pt1a-bn0g2-3.
Beskrivning

Breast Carcinoma | Disease lymph node positive | Disease Negative Lymph Node High risk | TNM clinical staging | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0746319
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0678034
UMLS CUI [3,3]
C0332167
UMLS CUI [4]
C3258246
UMLS CUI [5]
C0001779
2. primary surgery for breast cancer completed
Beskrivning

Breast Carcinoma Operative Surgical Procedure Primary Complete

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C0205197
3. completed 6 cycles of adjuvant (or neoadjuvant) chemotherapy containing anthracycline
Beskrivning

Adjuvant Chemotherapy Containing Anthracyclines | Neoadjuvant Chemotherapy Containing Anthracyclines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0282564
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0282564
4. age ≥ 18 and < 70 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. eastern cooperative oncology group or who performance status < 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. written informed consent prior to beginning protocol specific procedures
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
7. laboratory requirements (within 5 weeks prior to end of radiation treatment or within 5 weeks prior to completion of baseline examinations):
Beskrivning

Laboratory Procedures Requirement | Therapeutic radiology procedure | Physical Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1514873
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0031809
neutrophils ≥ 1.1 10^9/l, platelets ≥ 100 10^9/l, hemoglobin ≥ 10 g/dl, asat and alat ≤ x 2.5 unl (if alp > 2.5 ≤ x 5 unl, then asat and alat ≤ x 1.5 unl), alp ≤ x 5 unl (if asat and alat > 1.5 ≤ x 2.5 unl, then alp ≤ 2.5 x unl), creatinine ≤ 175 umol/l
Beskrivning

Absolute neutrophil count | Blood Platelets | Hemoglobin | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201850
UMLS CUI [7]
C0201976
8. completed staging analysis including chest x-ray, bone scintigraphy or mri, liver ultrasound or liver ct scan
Beskrivning

Staging of disease Complete | Plain chest X-ray | Bone scintigraphy | Magnetic Resonance Imaging | Ultrasonography of liver | Computerized Tomography (CT Scan) of Liver

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449385
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0039985
UMLS CUI [3]
C3889015
UMLS CUI [4]
C0024485
UMLS CUI [5]
C0412534
UMLS CUI [6]
C2455874
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. other (than breast carcinoma) earlier or concomitant carcinoma, except for skin and in situ cervix cancer
Beskrivning

Carcinoma | Breast Carcinoma | Skin carcinoma | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0007097
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0699893
UMLS CUI [4]
C0851140
2. m1 breast cancer or locoregional recurrence of previously diagnosed breast cancer.
Beskrivning

malignant neoplasm of breast M1 | Breast cancer recurrent Local-Regional

Datatyp

boolean

Alias
UMLS CUI [1]
C2216706
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C1947913
3. earlier treatment with paclitaxel or docetaxel.
Beskrivning

Paclitaxel | docetaxel

Datatyp

boolean

Alias
UMLS CUI [1]
C0144576
UMLS CUI [2]
C0246415
4. pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by nci criteria (see appendix ii)
Beskrivning

Motor nerve Toxicity Pre-existing | Sensory nerve Toxicity Pre-existing | CTCAE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0501384
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C0501385
UMLS CUI [2,2]
C0600688
UMLS CUI [2,3]
C2347662
UMLS CUI [3]
C1516728
5. cardiac disease with symptoms classified as nyha ≥ 2
Beskrivning

NYHA

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
6. definite contraindications for the use of corticosteroids
Beskrivning

Medical contraindication Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
7. concurrent treatment with other experimental drugs
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
8. concurrent treatment with any other anti-cancer therapy (except for endocrine therapy and trastuzumab)
Beskrivning

cancer treatment | Hormone Therapy | trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0728747
9. pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Breast Cancer NCT00248703

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Disease lymph node positive | Disease Negative Lymph Node High risk | TNM clinical staging | Age
Item
1. breast cancer with node positive disease or high risk node negative disease (pt1c/t2gii-iiin0, pt3n0, ct3n0). patients < 35 years with pt1a-bn0g2-3.
boolean
C0678222 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0746319 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0678034 (UMLS CUI [3,2])
C0332167 (UMLS CUI [3,3])
C3258246 (UMLS CUI [4])
C0001779 (UMLS CUI [5])
Breast Carcinoma Operative Surgical Procedure Primary Complete
Item
2. primary surgery for breast cancer completed
boolean
C0678222 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Adjuvant Chemotherapy Containing Anthracyclines | Neoadjuvant Chemotherapy Containing Anthracyclines
Item
3. completed 6 cycles of adjuvant (or neoadjuvant) chemotherapy containing anthracycline
boolean
C0085533 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0282564 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0282564 (UMLS CUI [2,4])
Age
Item
4. age ≥ 18 and < 70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group or who performance status < 2
boolean
C1520224 (UMLS CUI [1])
Informed consent
Item
6. written informed consent prior to beginning protocol specific procedures
boolean
C0021430 (UMLS CUI [1])
Laboratory Procedures Requirement | Therapeutic radiology procedure | Physical Examination
Item
7. laboratory requirements (within 5 weeks prior to end of radiation treatment or within 5 weeks prior to completion of baseline examinations):
boolean
C0022885 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Absolute neutrophil count | Blood Platelets | Hemoglobin | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum
Item
neutrophils ≥ 1.1 10^9/l, platelets ≥ 100 10^9/l, hemoglobin ≥ 10 g/dl, asat and alat ≤ x 2.5 unl (if alp > 2.5 ≤ x 5 unl, then asat and alat ≤ x 1.5 unl), alp ≤ x 5 unl (if asat and alat > 1.5 ≤ x 2.5 unl, then alp ≤ 2.5 x unl), creatinine ≤ 175 umol/l
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201850 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Staging of disease Complete | Plain chest X-ray | Bone scintigraphy | Magnetic Resonance Imaging | Ultrasonography of liver | Computerized Tomography (CT Scan) of Liver
Item
8. completed staging analysis including chest x-ray, bone scintigraphy or mri, liver ultrasound or liver ct scan
boolean
C0449385 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0039985 (UMLS CUI [2])
C3889015 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0412534 (UMLS CUI [5])
C2455874 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Carcinoma | Breast Carcinoma | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
1. other (than breast carcinoma) earlier or concomitant carcinoma, except for skin and in situ cervix cancer
boolean
C0007097 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
malignant neoplasm of breast M1 | Breast cancer recurrent Local-Regional
Item
2. m1 breast cancer or locoregional recurrence of previously diagnosed breast cancer.
boolean
C2216706 (UMLS CUI [1])
C0278493 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
Paclitaxel | docetaxel
Item
3. earlier treatment with paclitaxel or docetaxel.
boolean
C0144576 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
Motor nerve Toxicity Pre-existing | Sensory nerve Toxicity Pre-existing | CTCAE
Item
4. pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by nci criteria (see appendix ii)
boolean
C0501384 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0501385 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C1516728 (UMLS CUI [3])
NYHA
Item
5. cardiac disease with symptoms classified as nyha ≥ 2
boolean
C1275491 (UMLS CUI [1])
Medical contraindication Adrenal Cortex Hormones
Item
6. definite contraindications for the use of corticosteroids
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Investigational New Drugs
Item
7. concurrent treatment with other experimental drugs
boolean
C0013230 (UMLS CUI [1])
cancer treatment | Hormone Therapy | trastuzumab
Item
8. concurrent treatment with any other anti-cancer therapy (except for endocrine therapy and trastuzumab)
boolean
C0920425 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0728747 (UMLS CUI [3])
Pregnancy
Item
9. pregnancy
boolean
C0032961 (UMLS CUI [1])
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