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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030739
Receipt No. R000035104
Scientific Title Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial
Date of disclosure of the study information 2018/01/09
Last modified on 2018/01/09

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Basic information
Public title Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial
Acronym Preoperative chemotherapy for resectable UICC7 StageIII HCC
Scientific Title Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial
Scientific Title:Acronym Preoperative chemotherapy for resectable UICC7 StageIII HCC
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze survival benefit of preoperative chemotherapy for in patients with resectable UICC StageIIIA, IIIB advanced hepatocellular carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The 3 years disease free survival rate after liver surgery
Key secondary outcomes Overall survival, disease free survival, response to the preoperative chemotherapy, incidence and degree of side effects of preoperative chemotherapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 As a preoperative chemotherapy, hepatic arterial infusion chemotherapy (HAIC) is performed, regimen of HAIC is New FP therapy. Angiography is performed on Day 1 as induction New FP and bolus injection is performed by suspending Lipiodol at a maximum of 10 ml and CDDP at a maximum of 50 mg according to the tumor diameter. Lastly, infuser pump containing 1250 mg of 5-FU is connected and administered continuously from Day 1 to Day 5, this is taken as one course. After the introduction therapy by completing the second course from Day 8 and the third course from Day 15 (for the case where tumor vascular embolism is insufficient at the end of 3 courses, the 4th course from day 22 is conducted and the introduction chemotherapy is terminated ).
New FP maintenance chemotherapy suspends CDDP up to 35 mg for Lipiodol maximum of 5 ml on Day 1 and terminates bolus injection at the time when whole tumor is filled with Lipiodol under angiography or when Lipiodol stagnates in tumor blood vessel . Continuous administration of infuser pump containing 1000 mg of 5-FU, continuous administration from Day 1 to Day 3, this is taken as one course. Maintain total of 3-4 courses with biweekly chemotherapy and complete preoperative chemotherapy. If there was a feeding artery other than the hepatic artery existed, TACE is added.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) A case of aged> or =20 years old.
2) Cases of UICC7 StageIIIA, IIIB diagnosed as hepatocellular carcinoma histologically or clinically (imaging diagnosis, tumor marker).
3) Cases of UICC7 StageIIIA, IIIB which can initially perform R0 resection at diagnosis.
4) Cases in which patient consent was obtained in the document after adequate explanation by the attending physician.
5) Patients who can expect survival for more than 3 months.
6) ECOG performance status 0 or 1.
7) Patients who had been preserved adequate major organ functions within 2 weeks before registration (bone marrow, heart, liver, kidney, etc.).
Neutrophils> or =1000/mm3
Hb> or =8.5 g/dl
Platelet> or =75,000/mm3
AST and ALT< or =200 IU/L
Child-Pugh score 7 points or less
Total bilirubin 3 mg/dl or less (Excluded after reduction of jaundice cases due to bile duct tumor obstructions)
No refractory ascites or hepatic encephalopathy
Other major organ functions are well preserved
Key exclusion criteria 1) Patients with history of advanced cancer in other organs within 5 years.
2) A patient who has history of chemotherapy of a regimen including CDDP or 5-FU.
2) Active infectious diseases (except for viral hepatitis)
3) Patients who have a history of allergy to iodine contrast agent, platinum-containing drug, or gelatin-containing drug / food.
4) Pregnant women, breast-feeding women and patients who may be pregnant.
Patients who are determined by the attending physician to be inappropriate for this examination for other reasons (in cases where the patient does not obey the instructions or has problems with family cooperation etc.).
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Okuda
Organization Kurume University
Division name Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery
Zip code
Address 67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL 0942-31-7567
Email kook@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Goto
Organization Kurume University
Division name Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery
Zip code
Address 67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL 0942-31-7567
Homepage URL
Email gotou_yuuichi@med.kurume-u.ac.jp

Sponsor
Institute Kurume University, Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery
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
Address
Tel
Email

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
2018 Year 01 Month 09 Day

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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
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
2018 Year 01 Month 09 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035104

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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