UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002398 |
|---|---|
| Receipt number | R000002943 |
| Scientific Title | Phase II study of intensive chemotherapy in treating pediatric patients with newly diagnosed cranial nongerminomaous germ cell tumor |
| Date of disclosure of the study information | 2009/08/28 |
| Last modified on | 2015/09/10 12:10:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of intensive chemotherapy in treating pediatric patients with newly diagnosed cranial nongerminomaous germ cell tumor
Acronym
Intensive chemotherapy in treating pediatric patients with cranial nongerminomaous germ cell tumor
Scientific Title
Phase II study of intensive chemotherapy in treating pediatric patients with newly diagnosed cranial nongerminomaous germ cell tumor
Scientific Title:Acronym
Intensive chemotherapy in treating pediatric patients with cranial nongerminomaous germ cell tumor
Region
| Japan |
Condition
Condition
Cranial nongerminomatous germ cell tumor
Classification by specialty
| Pediatrics | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determine whether intensive multiagent chemotherapy and radiotherapy improve outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3-year progression-free survival
Key secondary outcomes
3-year overall survival
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
Patients receive chemotherapy consisting of cyclophosphamide, etoposide, cisplatin. Chemotherapy repeats every 4 weeks for 5 courses. Radiation doses are 50 Gy to the primary site. High-risk patients with metastasis or refractory disease receive high-dose chemotherapy consisting of etoposide and carboplatin.
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
| 3 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosis of germ cell tumor, and 2-a) or b).
2-a) AFP > upper limit of normal or beta hCG > 50 ng/ml.
2-b) The element of yolk sac tumor, choriocarcinoma, or embryonal carcinoma is contained in the tissue.
3. Has undergone biopsy within the past 42 days.
4. No prior radiation therapy or chemotherapy.
5. PS score: 0-3.
6. WBC >2000/mm3, ANC >1000/mm3, Platelet count >100000/mm3
7. ALT <100 IU/ml, Billirubin <1.5 mg/dl, Serum creatinine < upper limit of normal.
8. Normal electorocardiogram.
Key exclusion criteria
Has double cancer.
Has cardiac disease for which treatment is necessary.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Kosaka |
Organization
Hyogo Prefectural Kobe Children's Hospital
Division name
Hematology and Oncology
Zip code
Address
1-1-1 Takakuradai, Suma-Ku, Kobe, Hyogo 654-0081 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Okada |
Organization
Osaka City General Hospital
Division name
Pediatric Hematology/Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Japanese Pediatric Brain Tumor Consortiun
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 08 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 05 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 28 | Day |
Last modified on
| 2015 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002943
