ID

17915

Beschrijving

Photodynamic Therapy With Talaporfin Sodium (LS11) in Treating Patients With Refractory Colorectal Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00068068

Link

https://clinicaltrials.gov/show/NCT00068068

Trefwoorden

Versies (2)
  1. 08-10-16 08-10-16 -
  2. 08-10-16 08-10-16 -
Geüploaded op

8 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Liver Metastasis NCT00068068

Engels

Eligibility Liver Metastasis NCT00068068

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic disease.
Beschrijving

Lesion of liver Metastatic Due to colorectal disorder | Metastatic Neoplasm Chemotherapy failed | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0036525
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C2103078
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0242656
biopsy proven evidence of colorectal cancer.
Beschrijving

Colorectal Carcinoma Evidence of | Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0005558
patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter.
Beschrijving

Lesion Quantity | Lesion size | Lesion Diameter Maximum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0449453
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0806909
age greater than or equal to 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients must be able to sign informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
life expectancy greater than or equal to 3 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0-2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following litx therapy.
Beschrijving

Disease Extrahepatic | Secondary malignant neoplasm of liver | systemic therapy Disease Extrahepatic | Therapies, Investigational

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
UMLS CUI [2]
C0494165
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1517058
UMLS CUI [4]
C0949266
off chemotherapy for 4 weeks. must have recovered from the chemotherapy effects.
Beschrijving

Chemotherapy ended | Chemotherapy Effects Patients Recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2746065
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C0521108
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must be excluded if any of the following apply:
Beschrijving

Patients Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C2828389
patients who are candidates for complete surgical resection.
Beschrijving

Indication Complete excision

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0015250
pregnancy or breast-feeding. a negative pregnancy test (urine or serum) is required prior to enrollment.
Beschrijving

Pregnancy | Breast Feeding | Urine pregnancy test negative Patient need for | Serum pregnancy test negative Patient need for

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0430057
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C0430061
UMLS CUI [4,2]
C0686904
known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.
Beschrijving

Allergic Reaction Serious Uncontrolled Contrast Media Investigational | anaphylaxis Contrast Media Investigational

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [1,4]
C0009924
UMLS CUI [1,5]
C1517586
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0009924
UMLS CUI [2,3]
C1517586
pt or ptt greater than 1.5x control.
Beschrijving

Prothrombin time | Partial Thromboplastin Time measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0030605
platelet count less than 100,000.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
wbc less than 2500/mm.
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
neutrophils less than 2000/mm.
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin less than 9 g/dl.
Beschrijving

Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
liver enzymes greater than 3 x uln.
Beschrijving

liver enzymes

Datatype

boolean

Alias
UMLS CUI [1]
C1287351
total bilirubin greater than 1.5 x uln.
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine greater than 2.5 x uln.
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
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Similar models

Eligibility Liver Metastasis NCT00068068

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Lesion of liver Metastatic Due to colorectal disorder | Metastatic Neoplasm Chemotherapy failed | Disease Progression
Item
patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic disease.
boolean
C0577053 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C2103078 (UMLS CUI [1,4])
C2939420 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3])
Colorectal Carcinoma Evidence of | Biopsy
Item
biopsy proven evidence of colorectal cancer.
boolean
C0009402 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
Lesion Quantity | Lesion size | Lesion Diameter Maximum
Item
patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter.
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0449453 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0806909 (UMLS CUI [3,3])
Age
Item
age greater than or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patients must be able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than or equal to 3 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Disease Extrahepatic | Secondary malignant neoplasm of liver | systemic therapy Disease Extrahepatic | Therapies, Investigational
Item
patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following litx therapy.
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0494165 (UMLS CUI [2])
C1515119 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1517058 (UMLS CUI [3,3])
C0949266 (UMLS CUI [4])
Chemotherapy ended | Chemotherapy Effects Patients Recovered
Item
off chemotherapy for 4 weeks. must have recovered from the chemotherapy effects.
boolean
C0392920 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0521108 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Patients Excluded
Item
patients must be excluded if any of the following apply:
boolean
C0030705 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Indication Complete excision
Item
patients who are candidates for complete surgical resection.
boolean
C3146298 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Urine pregnancy test negative Patient need for | Serum pregnancy test negative Patient need for
Item
pregnancy or breast-feeding. a negative pregnancy test (urine or serum) is required prior to enrollment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430057 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0430061 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Allergic Reaction Serious Uncontrolled Contrast Media Investigational | anaphylaxis Contrast Media Investigational
Item
known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.
boolean
C1527304 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0009924 (UMLS CUI [1,4])
C1517586 (UMLS CUI [1,5])
C0002792 (UMLS CUI [2,1])
C0009924 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
Prothrombin time | Partial Thromboplastin Time measurement
Item
pt or ptt greater than 1.5x control.
boolean
C0033707 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count less than 100,000.
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc less than 2500/mm.
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
neutrophils less than 2000/mm.
boolean
C0948762 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin less than 9 g/dl.
boolean
C0019046 (UMLS CUI [1])
liver enzymes
Item
liver enzymes greater than 3 x uln.
boolean
C1287351 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin greater than 1.5 x uln.
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine greater than 2.5 x uln.
boolean
C0201976 (UMLS CUI [1])
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