ID

26635

Beschreibung

A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00793962

Link

https://clinicaltrials.gov/show/NCT00793962

Stichworte

Versionen (2)
  1. 19.10.17 19.10.17 -
  2. 22.10.17 22.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. Oktober 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00793962

Englisch

Eligibility Breast Cancer NCT00793962

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ipsilateral histologically confirmed invasive breast cancer
Beschreibung

Invasive carcinoma of breast Ipsilateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0441989
undergone total mastectomy and axillary dissection
Beschreibung

Total mastectomy | Excision of axillary lymph nodes

Datentyp

boolean

Alias
UMLS CUI [1]
C0024886
UMLS CUI [2]
C0193867
t3-4,or >=4 positive axillary lymph nodes
Beschreibung

Positive Axillary Lymph Node TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677929
UMLS CUI [1,2]
C3258246
fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
Beschreibung

Fit Chemotherapy | Fit Hormone Therapy | Fit Therapeutic radiology procedure Postoperative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C0424576
UMLS CUI [2,2]
C0279025
UMLS CUI [3,1]
C0424576
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0032790
written,informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
ct3-4,or cn2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
Beschreibung

Positive Axillary Lymph Node TNM clinical staging | Mastectomy | Chemotherapy Neoadjuvant | Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677929
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0024881
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
UMLS CUI [4]
C0279025
no supraclavicular or internal mammary nodes metastases
Beschreibung

Secondary malignant neoplasm of supraclavicular lymph nodes Absent | Internal Mammary Lymph Node Metastases Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686637
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0229755
UMLS CUI [2,2]
C0027627
UMLS CUI [2,3]
C0332197
no distant metastases
Beschreibung

Distant metastasis Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
Beschreibung

Enrollment Date | Operative Surgical Procedures | Chemotherapy | Neoadjuvant Therapy Systemic Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C0205373
UMLS CUI [4,3]
C0332197
enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.
Beschreibung

Enrollment Date | Operative Surgical Procedures | Neoadjuvant Therapy Systemic | Adjuvant Chemotherapy Redundant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0543467
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C0085533
UMLS CUI [4,2]
C1313915
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
Beschreibung

Irradiation of chest wall Ipsilateral | Therapeutic radiology procedure Region supraclavicular Ipsilateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2064934
UMLS CUI [1,2]
C0441989
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0446461
UMLS CUI [2,3]
C0441989
previous or concurrent malignant other than non-melanomatous skin cancer
Beschreibung

Malignant Neoplasms | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
unable or unwilling to give informed consent
Beschreibung

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
bilateral breast cancer
Beschreibung

bilateral breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0281267
immediate or delayed ipsilateral breast cancer reconstruction
Beschreibung

Breast Carcinoma Mammaplasty Ipsilateral Immediate | Breast Carcinoma Mammaplasty Ipsilateral Delayed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0085076
UMLS CUI [1,3]
C0441989
UMLS CUI [1,4]
C0205253
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0085076
UMLS CUI [2,3]
C0441989
UMLS CUI [2,4]
C0205421
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Ähnliche Modelle

Eligibility Breast Cancer NCT00793962

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Ipsilateral
Item
ipsilateral histologically confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
Total mastectomy | Excision of axillary lymph nodes
Item
undergone total mastectomy and axillary dissection
boolean
C0024886 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
Positive Axillary Lymph Node TNM clinical staging
Item
t3-4,or >=4 positive axillary lymph nodes
boolean
C0677929 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Fit Chemotherapy | Fit Hormone Therapy | Fit Therapeutic radiology procedure Postoperative
Item
fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
boolean
C0424576 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0424576 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0424576 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0032790 (UMLS CUI [3,3])
Informed Consent
Item
written,informed consent
boolean
C0021430 (UMLS CUI [1])
Positive Axillary Lymph Node TNM clinical staging | Mastectomy | Chemotherapy Neoadjuvant | Hormone Therapy
Item
ct3-4,or cn2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
boolean
C0677929 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0279025 (UMLS CUI [4])
Secondary malignant neoplasm of supraclavicular lymph nodes Absent | Internal Mammary Lymph Node Metastases Absent
Item
no supraclavicular or internal mammary nodes metastases
boolean
C0686637 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0229755 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Distant metastasis Absent
Item
no distant metastases
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Enrollment Date | Operative Surgical Procedures | Chemotherapy | Neoadjuvant Therapy Systemic Absent
Item
enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
boolean
C1516879 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0600558 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Enrollment Date | Operative Surgical Procedures | Neoadjuvant Therapy Systemic | Adjuvant Chemotherapy Redundant
Item
enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.
boolean
C1516879 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0600558 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0085533 (UMLS CUI [4,1])
C1313915 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Irradiation of chest wall Ipsilateral | Therapeutic radiology procedure Region supraclavicular Ipsilateral
Item
patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
boolean
C2064934 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0446461 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Skin carcinoma
Item
previous or concurrent malignant other than non-melanomatous skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
bilateral breast cancer
Item
bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Breast Carcinoma Mammaplasty Ipsilateral Immediate | Breast Carcinoma Mammaplasty Ipsilateral Delayed
Item
immediate or delayed ipsilateral breast cancer reconstruction
boolean
C0678222 (UMLS CUI [1,1])
C0085076 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0205253 (UMLS CUI [1,4])
C0678222 (UMLS CUI [2,1])
C0085076 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
C0205421 (UMLS CUI [2,4])
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