UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022324 |
|---|---|
| Receipt number | R000025721 |
| Scientific Title | Pilot study of the combination of sorafenib and fractionated irinotecan in pediatric relapse/refractory hepatic cancer |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2023/10/20 17:49:56 |
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Basic information
Public title
Pilot study of the combination of sorafenib and fractionated irinotecan in pediatric relapse/refractory hepatic cancer
Acronym
Pilot study of sorafenib/irinotecan combination therapy in pediatric liver cancer
Scientific Title
Pilot study of the combination of sorafenib and fractionated irinotecan in pediatric relapse/refractory hepatic cancer
Scientific Title:Acronym
Pilot study of sorafenib/irinotecan combination therapy in pediatric liver cancer
Region
| Japan |
Condition
Condition
hepatoblastoma and hepatocellular carcinoma of children
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of the sorafenib + irinotecan combination therapy in childhood patients with refractory liver cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Dose limiting toxicity in the sorafenib + irinotecan combination therapy
Key secondary outcomes
occurrence of adverse events
AFP after the treatment
tumors size/number after the treatment
6 months non-progress survival/overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
irinotecan i.v. at 20 mg/m2 x 5 or 10 days combined with sorafenib at 400 mg/m2 x 28 days
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who have not achieved PR or CR by 2 different chemotherapy regimens before enrollment
2. with unresectable or metastatic diseases (or with abnormal serum AFP>10 ng/ml which has elevated in 2 consecutive evaluation with at least 2 weeks interval)
3. ECOG PS score = 0 - 2
4. with normal organ function
5. with informed consent
6. no other chemotherapy has been administered 14 days before enrollment.
Key exclusion criteria
1. active infectious disease
2. congenital or acquired immunodeficiency
3. inadequate case by physician's judgement
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Goto |
Organization
Kanagawa Children's Medical Center
Division name
Division of Hemato-Oncology and Regenerative Medicine
Zip code
Address
2-138-4 Mutsukawa Minami-ku, Yokohama
TEL
0457112351
hgotou@kcmc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Goto |
Organization
Kanagawa Children's Medical Center
Division name
Division of Hemato-Oncology and Regenerative Medicine
Zip code
Address
2-138-4 Mutsukawa Minami-ku, Yokohama
TEL
0457112351
Homepage URL
hgotou@kcmc.jp
Sponsor or person
Institute
Kanagawa Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2016 | Year | 05 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025721
