UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001138 |
|---|---|
| Receipt number | R000001369 |
| Scientific Title | A randomized controlled trial of intra-arterial infusion of CDDP for hepatocellular carcinoma to prevent intra-hepatic metastasis after curative resection |
| Date of disclosure of the study information | 2008/05/01 |
| Last modified on | 2017/04/01 20:06:56 |
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Basic information
Public title
A randomized controlled trial of intra-arterial infusion of CDDP for hepatocellular carcinoma to prevent intra-hepatic metastasis after curative resection
Acronym
Efficacy of intra-arterial infusion of CDDP after curative resection of hepatocellular carcinoma
Scientific Title
A randomized controlled trial of intra-arterial infusion of CDDP for hepatocellular carcinoma to prevent intra-hepatic metastasis after curative resection
Scientific Title:Acronym
Efficacy of intra-arterial infusion of CDDP after curative resection of hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Patients after curative resection of hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Hepatocellular carcinoma shows a high recurrent rate of 50 to 70% by 3 years after curative resection. A following treatment for the recurrence is restricted depending on the reduction of hepatic reserve. Therefore, it is critical to establish a preventive means for the recurrence in order to improve the survival and quality of life in patients with hepatocellular carcinoma.
Hepatocellular carcinoma appears to recurrent as de novo or metastasis. It is reported that a successful treatment for a background liver disease significantly reduced de novo cancer development. On the other hand, to date no standard therapy has been established in terms of the prevention of the metastatic disease.
In this trial, cases after curative resection of hepatocellular carcinoma are randomly divided into two groups: a) a group with no additional treatment and b) a group with an intra-arterial infusion of CDDP. At first, the safety issue of the infusion is evaluated. Then, the benefit of the infusion is evaluated on the basis of survival and recurrence-free survival. The effect of the infusion on a way of recurrence is also evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
1. Survival
2. Recurrence-free survival based on the evaluation using computed tomography, magnetic resonance imaging or ultrasound. The evaluation should be conducted every three months and has to be performed with computed tomography or magnetic resonance imaging at least once a 6-months.
3. A way of recurrence
Key secondary outcomes
1. RBC, WBC including differential count, Plt, PT-INR , Bleeding time
2. TP, Alb, AST, ALT, ALP, LDH, gamma-GTP, TBil, BUN, Crt, Na, K, Cl, ChE, T Chol, HbA1c
3. Alpha-fetoprotein, Fucosylated fraction of alpha-fetoprotein, Des-gamma-carboxy prothrombin
4. Urinalysis, Creatinine clearance
5. Background
a. Age, Gender, Performance status, Chest X-ray, ECG
b. HBsAg, anti-HCV, Child-Pugh classification, Indocyanine green retention rate R15 and clearance rate
c. Characteristics of hepatocellular carcinoma: diagnostic modality, size, number, location, extension to hepatic and/or portal vein
d. Alcoholic consumption, Blood transfusion, History of treatment for hepatocellular carcinoma and/or other diseases, History of allergy
Items from #1 to #3 and #4 are evaluated once a month and just before each infusion of CDDP, respectively, while those in #5 are evaluated only at the enrolment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: No additional treatment after curative resection
Interventions/Control_2
Group B: Intra-arterial infusion of CDDP after curative resection
An amount of 65mg/square meter of body surface of CDDP dissolved in saline at the concentration of 100 mg/70 ml is infused targeting the entire residual liver through a catheter inserted into an appropriate artery on 8, 20 and 32 weeks after curative surgical resection of hepatocellular carcinoma. The infusion rate is 3 mg/min, and two weeks earlier or later date is acceptable. When creatinine clearance is less than 90 ml/min or 70 ml/min, the amount of CDDP is reduced to 70% or 50%, respectively. If the previous infusion required additional treatments against adverse effects at Grade 3 of Common Terminology Criteria for Adverse Events v3.0 in terms of WBC, RBC and/or Plt, the amount of CDDP is reduced to 80% in the following infusion.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Performance status is less than 2.
2. Child-Pugh classification is A or B.
3. The following criteria are satisfied.
a. WBC is more than 3,000/microliter.
b. Plt is more than 50,000/microliter.
c. Hb is more than 8.0 g/dl.
d. Total bilirubin is 3.0 g/dl or less.
e. Creatinine clearance adjusted by a body square meter of 1.73 is more than 50 ml/min.
4. There are no other active malignant diseases.
5. No additional anti-cancer treatments have been executed for the last three months, which affect on over the liver.
6. A patient can give informed consent by himself/herself.
Key exclusion criteria
1. The history of severe allergic reaction against iodinated contrast medium and/or platinum-containing drugs.
2. A woman who is pregnant, lactating, or may become pregnant.
3. Hepatocellular carcinoma extended to the first branch of the portal vein or further.
4. Hepatocellular carcinoma extended to the inferior vena cava or further.
5. Dynamic CT or dynamic MRI revealed that hepatocellular carcinoma is solitary and 2 cm or less without vascular invasion.
6. Under interferon therapy.
7. A doctor responsible for the study judged to be inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Suda |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-757 Asahi-Machi, Chuo-Ku, Niigata, Niigata 951-8122
TEL
025-227-2207
tspitt@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Kubota |
Organization
Niigata Hepatocellular Carcinoma Therapy Study Group
Division name
Executive Office
Zip code
Address
1-757 Asahi-Machi, Chuo-Ku, Niigata, Niigata 951-8122
TEL
025-227-2207
Homepage URL
t-kubota@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Hepatocellular Carcinoma Therapy Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 28 | Day |
Last modified on
| 2017 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001369
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