ID

36272

Beschreibung

Phase I:Decitabine by Hepatic Arterial Infusion(HAI) in Unresectable Liver Metastases Colorectal Cancer (CRC); ODM derived from: https://clinicaltrials.gov/show/NCT02316028

Link

https://clinicaltrials.gov/show/NCT02316028

Stichworte

Versionen (1)
  1. 27.04.19 27.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. April 2019

DOI

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Creative Commons BY 4.0
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Eligibility Liver Metastasis NCT02316028

Englisch

Eligibility Liver Metastasis NCT02316028

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological documentation of colorectal adenocarcinoma crc stage iv with predominant unresectable liver metastases and at least one measurable metastatic liver lesion
Beschreibung

Adenocarcinoma of large intestine | Colorectal Carcinoma TNM clinical staging | Secondary malignant neoplasm of liver unresectable | Lesion of liver metastatic measurable Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C1319315
UMLS CUI [2,1]
C0009402
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C0577053
UMLS CUI [4,2]
C1522484
UMLS CUI [4,3]
C1513040
UMLS CUI [4,4]
C1265611
performance status who criteria of < 2.
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
laboratory values: absolute neutrophil count (anc) count > 1500 /mm³, platelet count > 100 000 /mm³, lymphocytes > 800 /mm³, serum creatinine < 2.0 mg/dl or creatinine clearance >40 ml/min, serum bilirubin < 2.0 mg/dl
Beschreibung

Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Lymphocyte Count measurement | Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0200635
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0373595
UMLS CUI [7]
C1278039
progressive disease following standard of care palliative systemic chemotherapy
Beschreibung

Progressive Disease | Status post Systemic Chemotherapy Palliative

Datentyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1883256
UMLS CUI [2,3]
C1285530
able to give written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
no prior radiotherapy to all target liver lesions
Beschreibung

Prior radiation therapy Lesion of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0577053
no previous history of gastric or hepatobiliary surgery (except for simple cholecystectomy, no concurrent liver disease or other serious medical disease or condition
Beschreibung

Operation on stomach | Operative Surgical Procedures Hepatobiliary System | Exception Cholecystectomy Simple | Liver disease Concurrent | Disease Serious | Other medical condition Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C0192398
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1711359
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0008320
UMLS CUI [3,3]
C0205352
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0205420
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205404
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205404
no concomitant use of other investigational drugs.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
no pre-existing neuropathy with a severity of > grade 1 in the who toxicity scale.
Beschreibung

Neuropathy Pre-existing Toxicity Grade

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0600688
UMLS CUI [1,4]
C0441800
no previous or concurrent malignancies except for adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or any other malignancy given potentially curative treatment more than 5 years before study entry
Beschreibung

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative treatment Cancer Other

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C1707251
no pregnant or breast-feeding female patients, use of an effective contraceptive if the risk of conception exists during study treatment.
Beschreibung

Pregnancy | Breast Feeding | At risk of unplanned pregnancy Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3839721
UMLS CUI [3,2]
C0700589
no candidate for the resection of all crc metastases with curative intent.
Beschreibung

Colorectal Carcinoma Metastasis | Excision Curative intent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C1276305
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Ähnliche Modelle

Eligibility Liver Metastasis NCT02316028

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine | Colorectal Carcinoma TNM clinical staging | Secondary malignant neoplasm of liver unresectable | Lesion of liver metastatic measurable Quantity
Item
histological documentation of colorectal adenocarcinoma crc stage iv with predominant unresectable liver metastases and at least one measurable metastatic liver lesion
boolean
C1319315 (UMLS CUI [1])
C0009402 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0494165 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0577053 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
C1513040 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
WHO performance status scale
Item
performance status who criteria of < 2.
boolean
C1298650 (UMLS CUI [1])
Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Lymphocyte Count measurement | Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement
Item
laboratory values: absolute neutrophil count (anc) count > 1500 /mm³, platelet count > 100 000 /mm³, lymphocytes > 800 /mm³, serum creatinine < 2.0 mg/dl or creatinine clearance >40 ml/min, serum bilirubin < 2.0 mg/dl
boolean
C1254595 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0200635 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
Progressive Disease | Status post Systemic Chemotherapy Palliative
Item
progressive disease following standard of care palliative systemic chemotherapy
boolean
C1335499 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1883256 (UMLS CUI [2,2])
C1285530 (UMLS CUI [2,3])
Informed Consent
Item
able to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior radiation therapy Lesion of liver
Item
no prior radiotherapy to all target liver lesions
boolean
C0279134 (UMLS CUI [1,1])
C0577053 (UMLS CUI [1,2])
Operation on stomach | Operative Surgical Procedures Hepatobiliary System | Exception Cholecystectomy Simple | Liver disease Concurrent | Disease Serious | Other medical condition Serious
Item
no previous history of gastric or hepatobiliary surgery (except for simple cholecystectomy, no concurrent liver disease or other serious medical disease or condition
boolean
C0192398 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0008320 (UMLS CUI [3,2])
C0205352 (UMLS CUI [3,3])
C0023895 (UMLS CUI [4,1])
C0205420 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C3843040 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
Investigational New Drugs
Item
no concomitant use of other investigational drugs.
boolean
C0013230 (UMLS CUI [1])
Neuropathy Pre-existing Toxicity Grade
Item
no pre-existing neuropathy with a severity of > grade 1 in the who toxicity scale.
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative treatment Cancer Other
Item
no previous or concurrent malignancies except for adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or any other malignancy given potentially curative treatment more than 5 years before study entry
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
Pregnancy | Breast Feeding | At risk of unplanned pregnancy Contraceptive methods
Item
no pregnant or breast-feeding female patients, use of an effective contraceptive if the risk of conception exists during study treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3839721 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Colorectal Carcinoma Metastasis | Excision Curative intent
Item
no candidate for the resection of all crc metastases with curative intent.
boolean
C0009402 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
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