UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002397
Receipt No. R000002942
Scientific Title Phase II study of combination chemotherapy in treating pediatric patients with newly diagnosed intracranial germinoma
Date of disclosure of the study information 2009/08/28
Last modified on 2015/09/10

* 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 combination chemotherapy in treating pediatric patients with newly diagnosed intracranial germinoma
Acronym Combination chemotherapy in treating pediatric patients with intracranial germinoma
Scientific Title Phase II study of combination chemotherapy in treating pediatric patients with newly diagnosed intracranial germinoma
Scientific Title:Acronym Combination chemotherapy in treating pediatric patients with intracranial germinoma
Region
Japan

Condition
Condition Cranial germinoma
Classification by specialty
Pediatrics Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Pure germinoma: Determine whether intensive chemotherapy improves outcome.
Germinoma with STGC: Determine whether intensive chemotherapy reduces local irradiation.
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 Germinoma: Patients receive chemotherapy consisting of etoposide and cisplatin. Chemotherapy repeats every 3 weeks for 4 courses. Radiation doses are 24 Gy to the primary site.
Germinoma with STGC: Patients receive chemotherapy consisting of cyclophosphamide, etoposide and cisplatin. Chemotherapy repeats every 4 weeks for 5 courses. Radiation doses are 24 Gy to the primary site.
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 1 of the following,
germinoma, germinoma with STGC.
2. AFP < upper limit of normal, beta hCG < 50 ng/ml.
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 50

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
Email

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
Email

Sponsor
Institute Japanese Pediatric Brain Tumor Consortium
Institute
Department

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
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
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
2017 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002942

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.