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

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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


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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name