UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020748 |
|---|---|
| Receipt number | R000023946 |
| Scientific Title | Multi-center clinical trial for Japanese children with bilateral nephroblastoma(RTBL14) |
| Date of disclosure of the study information | 2016/01/26 |
| Last modified on | 2022/08/01 11:48:53 |
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Basic information
Public title
Multi-center clinical trial for Japanese children with bilateral nephroblastoma(RTBL14)
Acronym
Clinical trial for bilateral nephroblastoma
Scientific Title
Multi-center clinical trial for Japanese children with bilateral nephroblastoma(RTBL14)
Scientific Title:Acronym
Clinical trial for bilateral nephroblastoma
Region
| Japan |
Condition
Condition
nephroblastoma
Classification by specialty
| Pediatrics | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This trial is part of the third generation of clinical trials run by the JWiTS group. Wilms tumor (nephroblastoma) is the most common malignant renal neoplasm in children but the incidence is rare (approximately one by several ten thousands children per year). Therefore, 40-50 cases were registered to JWiTS a year. To identify the new effective regimen, nationwide clinical trials are needed. JWiTS was launched at 1996 and have performed JWiTS 1 and JWiTS 2 protocol studies. In these studies, multimodal therapy using actinomycin D, vincristine, and/or doxorubicin and radiation therapy was effective, and overall survival of the patients was improved to nearly 90 %. About 5-10 % of the Wilms tumors are arise bilaterally, and classified as stage V. In the previous studies, the survival of the bilateral cases was improved to around 90%. However in terms of renal preservation, nephrectomy was performed in two thirds of the patients. These results were not satisfactory, therefore new study protocol to improve the renal preservation is necessary to create.
In this protocol, chemotherapy is performed first without tumor biopsy to reduce the tumor size. After chemotherapy, nephron-sparing tumor resection will be performed. To identify the resectability, evaluation of the CT images after chemotherapy will be performed by the specialized JWiTS radiologists. The protocol study was opened in 2014, and national-wide multi-center clinical trial is now undergoing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of the bilateral renal preservation at 1 year after registration
Key secondary outcomes
Overall survival, disease free survival, recurrence rate, disease specific survival
Rate of hemilateral/bilateral nephrectomy
Rate of renal dysfunction
Rate of renal failure
Rate of toxicities
Evaluation of pathological findings after chemotherapy by JWiTS specified pathologists
Response rate to neo-adjuvant chemotherapy evaluated by the specified radiologists.
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
| Medicine |
Interventions/Control_1
Chemotherapy regimen DD-4A using actinomycin D (ACD), vincristine (VCR) and are administered for 6 or 12 weeks.
ACD iv for 0.045 mg/kg on week 1, 7, 13, 19 and 25.
VCR iv for 0.05mg/kg is started at week 2 and continued every week.
DOX iv for 1.5mg/kg on Week 4 and 10, and 1.0mg/kg on week 16 and 22.
The tumor size is measured by image analysis at week 6 and 12.
If nephron sparing surgery is possible, the tumor will be completely resected and post-operative chemotherapy and/or radiotherapy will be performed according to the operational findings and pathological diagnosis.
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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Radiologicaly confirmed bilateral nephroblastoma. If pathological diagnosis is different, the patient will be excluded after surgery.
2) Age < 18 years
3) No previous chemotherapy, radiotherapy or surgery
4) Written informed consent and national/local ethics committee and regulatory approval
5) Ability to comply with requirements for submission of material for central review (radiology, and pathology)
Key exclusion criteria
Cases with one of the following factors
1)Recurrent disease
2)Active double cancer, synchronous or remission less than 5 years
3)Performance Status (ECOG/Zubrod Score) is 4 (Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair)
4)Severe organ failure (hematologic, liver, kidney, heart)
White blood cells < 2000/mm3
Platelets <100,000/mm3
Serum bilirubin > 2.5 x normal limit
Serum ALT > 2.5 x normal limit
Serum total bile acid > 2.5 x normal limit
Serum creatinine > 2.5 x normal limit
5) Patient unable to undergo chemotherapy due to other disease, or the attending doctor considers inappropriate to entry this study.
6)The patient has a psychological disorder so that unable for entry.
7)Patient unable to tolerate the chemotherapy for any reason
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaharu Oue |
Organization
Hyogo College of Medicine
Division name
Pediatric Surgery
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6582
ta-oue@tho-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaharu Oue |
Organization
Hyogo College of Medicine
Division name
Pediatric Surgery
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6582
Homepage URL
http://jwits.umin.ac.jp/
ta-oue@hyo-med.ac.jp
Sponsor or person
Institute
Japan Children's Cancer Group(JCCG) (Japan Wilms Tumor Study Group, JWiTS)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
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
兵庫医科大学病院（兵庫県）他１１７施設
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
http://jwits.umin.ac.jp/
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023946
