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ID
16950
Beschreibung
Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00155272
Link
https://clinicaltrials.gov/show/NCT00155272
Stichworte
Versionen (2)
- 15.08.16 15.08.16 -
- 17.09.21 17.09.21 -
Hochgeladen am
15. August 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00155272
Eligibility Hepatocellular Carcinoma NCT00155272
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Hepatocellular Carcinoma NCT00155272
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Patients with measurable, locally advanced hcc that are not suitable for other local therapies
Item
1.1 patients with measurable, locally advanced hcc that are not suitable for other local therapies, including surgery, tae, alcohol injection, or radiofrequency ablation.
boolean
C2239176 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C1517925 (UMLS CUI [1,3])
C0677984 (UMLS CUI [1,2])
C1517925 (UMLS CUI [1,3])
liver carcinoma or chronic viral hepatitis and/or cirrhosis or presence of hepatic tumor with image findings
Item
1.2 patients with histological confirmed hcc or patients who do not have histological diagnosis but have met all of the following criteria: 1.2.1 presence of chronic viral hepatitis and/or cirrhosis 1.2.2 presence of hepatic tumor(s) with image findings (sonography, ct scan) compatible with hcc.
boolean
C2239176 (UMLS CUI [1])
C0276623 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0023903 (UMLS CUI [4,1])
C0011923 (UMLS CUI [4,2])
C0276623 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0023903 (UMLS CUI [4,1])
C0011923 (UMLS CUI [4,2])
Serum a-fetoprotein
Item
1.2.3 a persistent elevation of serum a-fetoprotein level ³ 400 ng/ml without any evidence of ana-fetoprotein-secreting germ cell tumor.
boolean
C0546833 (UMLS CUI [1])
no local or systemic therapy for hcc
Item
1.3 patients without any local or systemic therapy for hcc within 4 weeks.
boolean
C0087111 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,2])
Age
Item
1.4 patients with age > 20 years and < 70 years.
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
1.5 patients with a performance status of ecog score <1
boolean
C1520224 (UMLS CUI [1])
child-pugh score
Item
1.6 patients must fulfill all of the following criteria: 1.6.1 child-pugh’s score ≦ 7.
boolean
C2347612 (UMLS CUI [1])
Serum total bilirubin
Item
1.6.2 serum total bilirubin < 1.5 times upper normal limit (unl)
boolean
C1278039 (UMLS CUI [1])
ALT
Item
1.6.3 serum alanine transaminase (alt) < 5 times unl
boolean
C0201836 (UMLS CUI [1])
Platelet count
Item
1.6.4 platelet count > 5.0 x 104 / mm3.
boolean
C0032181 (UMLS CUI [1])
WBC
Item
1.6.5 white blood cell count > 3,000 / mm3.
boolean
C0023508 (UMLS CUI [1])
Serum creatinine
Item
1.6.6 serum creatinine < 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
local tumors less than one half of the whole liver
Item
1.7 patient must have local tumors less than one half of the whole liver and the tumors can be encompassed within rt fields
boolean
C0475440 (UMLS CUI [1])
Informed Consent
Item
1.8 signed informed consent
boolean
C0021430 (UMLS CUI [1])
Contraception, Thalidomide
Item
1.9 sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after, thalidomide therapy.
boolean
C0700589 (UMLS CUI [1])
C0039736 (UMLS CUI [2])
C0039736 (UMLS CUI [2])
Pregnancy test
Item
1.10 female patients in child-bearing age must have negative pregnancy test.
boolean
C0032976 (UMLS CUI [1])
Extrahepatic metastasis
Item
2.1. patients with documented extrahepatic metastasis.
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,2])
Previous radiotherapy to abdominal area
Item
2.2. patients who received previous radiotherapy to abdominal area.
boolean
C1997554 (UMLS CUI [1])
Thalidomide
Item
2.3. patients who have received thalidomide treatment prior to enrollment.
boolean
C0039736 (UMLS CUI [1])
Other investigational drug treatment
Item
2.4. patients who had other investigational drug treatment within 4 weeks prior to enrollment.
boolean
C2348568 (UMLS CUI [1])
nci grade 2 or greater peripheral neuropathy
Item
2.5. patients with nci grade 2 or greater peripheral neuropathy of any causes.
boolean
C0031117 (UMLS CUI [1,1])
C3887242 (UMLS CUI [1,2])
C3887242 (UMLS CUI [1,2])
Glucocorticosteroid or immunosuppressant agent
Item
2.6. patients with other systemic diseases that required concurrent usage of glucocorticosteroid or immunosuppressant agent(s).
boolean
C0038317 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0021081 (UMLS CUI [2])
major systemic diseases inappropriate for radiotherapy or thalidomide therapy
Item
2.7. patients who have major systemic diseases that the attending physicians consider inappropriate for radiotherapy or thalidomide therapy.
boolean
C0009488 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C1522449 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])