ID

16253

Description

A Trial of Gemcitabine Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00192062

Link

https://clinicaltrials.gov/show/NCT00192062

Keywords

Versions (1)
  1. 7/7/16 7/7/16 -
Uploaded on

July 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00192062

English

Eligibility Breast Cancer NCT00192062

1 forms  
Criteria
Description

Criteria

histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. lesions should not be amenable to surgery or radiation of curative intent.
Description

Breast Carcinoma | Unresectable Malignant Neoplasm | Locally Recurrent Malignant Neoplasm | Metastatic Neoplasm | Operative Surgical Procedures Curative | Therapeutic radiology procedure Curative

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C1336869
UMLS CUI [3]
C2986682
UMLS CUI [4]
C2939420
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C1276305
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C1276305
presence of metastatic or local-regional recurrent disease, according to the american joint committee on cancer (greenz, et al, 2002).
Description

Metastatic Neoplasm | Locally Recurrent Malignant Neoplasm | Recurrent tumor regional

Data type

boolean

Alias
UMLS CUI [1]
C2939420
UMLS CUI [2]
C2986682
UMLS CUI [3,1]
C0521158
UMLS CUI [3,2]
C0205147
uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (ct), chest x-ray or clinical examination, according to recist criteria (therasse, et al, 2002).
Description

Measurable Disease Linear | Margin Well defined | X-Ray Computed Tomography | chest X-ray | examination; clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [2,1]
C0205284
UMLS CUI [2,2]
C0442825
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0039985
UMLS CUI [5]
C1456356
no prior chemotherapy for metastatic or locoregionally recurrent disease. prior adjuvant or neoadjuvant chemotherapy with anthracyclines based regimen is mandatory. the time from the last dose of prior adjuvant chemotherapy and study entry must be at least 30 days and patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
Description

Prior Chemotherapy Metastatic Neoplasm | Prior Chemotherapy Locally Recurrent Malignant Neoplasm | Prior Chemotherapy Recurrent tumor regional | Adjuvant Chemotherapy Anthracyclines | Toxicities Due to Chemotherapy | Patient recovered | Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C2939420
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C2986682
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0521158
UMLS CUI [3,3]
C0205147
UMLS CUI [4,1]
C0085533
UMLS CUI [4,2]
C0282564
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0392920
UMLS CUI [6]
C1115804
UMLS CUI [7]
C0002170
prior radiotherapy must be completed at least 30 days before study entry.
Description

prior radiation therapy Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205197
no concurrent hormonal therapy for mbc. prior hormonal therapy is allowed, the time from the last dose of prior hormonal therapy for breast cancer to study enrollment must be at least 1 week.
Description

Hormone Therapy Metastatic Breast Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0278488
exclusion criteria -
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
have received treatment within the last 30 days with an investigational drug for any indication before study entry.
Description

Investigational New Drugs | Indication Any

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1552551
concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including herceptin).
Description

cancer treatment | Cytotoxic Chemotherapy | cancer surgery | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0677881
UMLS CUI [3]
C0920424
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0279025
UMLS CUI [6]
C0021083
UMLS CUI [7]
C0338204
active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
Description

Communicable Disease Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
pregnancy or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
Description

Comorbidity Affecting patient safety | Comorbidity Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
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Similar models

Eligibility Breast Cancer NCT00192062

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma | Unresectable Malignant Neoplasm | Locally Recurrent Malignant Neoplasm | Metastatic Neoplasm | Operative Surgical Procedures Curative | Therapeutic radiology procedure Curative
Item
histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. lesions should not be amenable to surgery or radiation of curative intent.
boolean
C0678222 (UMLS CUI [1])
C1336869 (UMLS CUI [2])
C2986682 (UMLS CUI [3])
C2939420 (UMLS CUI [4])
C0543467 (UMLS CUI [5,1])
C1276305 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C1276305 (UMLS CUI [6,2])
Metastatic Neoplasm | Locally Recurrent Malignant Neoplasm | Recurrent tumor regional
Item
presence of metastatic or local-regional recurrent disease, according to the american joint committee on cancer (greenz, et al, 2002).
boolean
C2939420 (UMLS CUI [1])
C2986682 (UMLS CUI [2])
C0521158 (UMLS CUI [3,1])
C0205147 (UMLS CUI [3,2])
Measurable Disease Linear | Margin Well defined | X-Ray Computed Tomography | chest X-ray | examination; clinical
Item
uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (ct), chest x-ray or clinical examination, according to recist criteria (therasse, et al, 2002).
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C0205284 (UMLS CUI [2,1])
C0442825 (UMLS CUI [2,2])
C0040405 (UMLS CUI [3])
C0039985 (UMLS CUI [4])
C1456356 (UMLS CUI [5])
Prior Chemotherapy Metastatic Neoplasm | Prior Chemotherapy Locally Recurrent Malignant Neoplasm | Prior Chemotherapy Recurrent tumor regional | Adjuvant Chemotherapy Anthracyclines | Toxicities Due to Chemotherapy | Patient recovered | Alopecia
Item
no prior chemotherapy for metastatic or locoregionally recurrent disease. prior adjuvant or neoadjuvant chemotherapy with anthracyclines based regimen is mandatory. the time from the last dose of prior adjuvant chemotherapy and study entry must be at least 30 days and patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
boolean
C1514457 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C2986682 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0521158 (UMLS CUI [3,2])
C0205147 (UMLS CUI [3,3])
C0085533 (UMLS CUI [4,1])
C0282564 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
C1115804 (UMLS CUI [6])
C0002170 (UMLS CUI [7])
prior radiation therapy Completed
Item
prior radiotherapy must be completed at least 30 days before study entry.
boolean
C0279134 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Hormone Therapy Metastatic Breast Cancer
Item
no concurrent hormonal therapy for mbc. prior hormonal therapy is allowed, the time from the last dose of prior hormonal therapy for breast cancer to study enrollment must be at least 1 week.
boolean
C0279025 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
Exclusion Criteria
Item
exclusion criteria -
boolean
C0680251 (UMLS CUI [1])
Investigational New Drugs | Indication Any
Item
have received treatment within the last 30 days with an investigational drug for any indication before study entry.
boolean
C0013230 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
cancer treatment | Cytotoxic Chemotherapy | cancer surgery | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Herceptin
Item
concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including herceptin).
boolean
C0920425 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C0920424 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C0021083 (UMLS CUI [6])
C0338204 (UMLS CUI [7])
Communicable Disease Compliance behavior Limited
Item
active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
boolean
C0009450 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Affecting patient safety | Comorbidity Compliance behavior Limited
Item
serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
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