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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004317 |
Receipt No. | R000005144 |
Scientific Title | Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial |
Date of disclosure of the study information | 2010/10/05 |
Last modified on | 2018/02/13 |
Basic information | ||
Public title | Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial
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Acronym | Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization | |
Scientific Title | Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization - A Randomized, Double-Blind, Placebo Controlled Trial
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Scientific Title:Acronym | Safety and Efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo Embolization | |
Region |
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Condition | ||
Condition | Hepatocellular Carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluation of safety and efficacy of Short-Term Steroid in Patients with Hepatocellular Carcinoma undergoing Transarterial Chemo-Embolization
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Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The proportion of patients with complete response, defined as no fever, no nausea, no vomiting, and no anorexia, during 120 hours after TACE. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | short term steroid administration | |
Interventions/Control_2 | Placebo | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images
2)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy) 3)Performance status (ECOG scale): 0,1 4)Child-Pugh A and B 5)Adequate bone marrow, liver, renal and cardiac function as assessed by the following a)Hemoglobin >= 8.5 g/dl b)Neutrophil >= 1000/mm3 c)Total bilirubin < 3.0mg/dl d)Liver transaminases <= 10 x Upper limit of Normal(ULN) e)PT(INR) <= 2.3 f)ALB >= 2.5 g/dl g)Cre <= 1.5 x ULN |
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Key exclusion criteria | 1)Second primary malignancy
2)Active infection 3)Extrahepatic metastasis 4)Epatoencepharopathy 5)Uncontrolable Pleural effusion and ascitis |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chiba University Hospital | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 1-8-1 Inohana, Chuou-ku, Chiba | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | Chiba University Hospital | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
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TEL | |||||||
Homepage URL | |||||||
ogasawaras@graduate.chiba-u.jp |
Sponsor | |
Institute | Chiba University Hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005144 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |