Information:
Fel:
ID
20409
Beskrivning
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00724503
Länk
https://clinicaltrials.gov/show/NCT00724503
Nyckelord
Versioner (1)
- 2017-02-21 2017-02-21 -
Uppladdad den
21 februari 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00724503
Eligibility Colorectal Cancer NCT00724503
- StudyEvent: Eligibility
Similar models
Eligibility Colorectal Cancer NCT00724503
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Liver metastases
Item
unequivocal and measurable ct evidence of liver metastases which are not treatable by surgical resection or local ablation.
boolean
C0494165 (UMLS CUI [1])
Extra-hepatic metastases
Item
limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm).
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,2])
Organ function
Item
suitable for either treatment regimen.
boolean
C0678852 (UMLS CUI [1])
Prior chemotherapy
Item
prior chemotherapy for metastatic colorectal cancer is not allowed.
boolean
C1514457 (UMLS CUI [1])
Performance status
Item
who performance status 0-1.
boolean
C1518965 (UMLS CUI [1])
Hematological, renal and hepatic function
Item
adequate hematological, renal and hepatic function.
boolean
C0541533 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Life expectancy
Item
life expectancy of at least 3 months without any active treatment.
boolean
C0023671 (UMLS CUI [1])
Comorbidity
Item
evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
boolean
C0009488 (UMLS CUI [1])
Previous radiotherapy
Item
previous radiotherapy delivered to the upper abdomen.
boolean
C1522449 (UMLS CUI [1])
Non-malignant disease which interferes with study protocol
Item
non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
boolean
C1513063 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Peripheral neuropathy
Item
peripheral neuropathy > grade 1 (nci-ctc).
boolean
C0031117 (UMLS CUI [1])
Dose limiting toxicity
Item
dose limiting toxicity with previous adjuvant 5-fu or oxaliplatin chemotherapy.
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,2])
Prior non-adjuvant chemotherapy
Item
prior non-adjuvant chemotherapy for any malignancy. adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
boolean
C1514457 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
C1522673 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
Gynaecological status
Item
pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Malignancy
Item
other active malignancy.
boolean
C0006826 (UMLS CUI [1])