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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004528
Receipt No. R000005381
Scientific Title A phase 2 study of radio-chemotherapy for primary intracranial germ cell tumors
Date of disclosure of the study information 2010/12/15
Last modified on 2010/12/15

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Basic information
Public title A phase 2 study of radio-chemotherapy for primary intracranial germ cell tumors
Acronym A phase 2 study for primary intracranial germ cell tumors
Scientific Title A phase 2 study of radio-chemotherapy for primary intracranial germ cell tumors
Scientific Title:Acronym A phase 2 study for primary intracranial germ cell tumors
Region
Japan

Condition
Condition primary intracranial germ cell tumors
Classification by specialty
Pediatrics Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of post-operative histology-oriented radiotherapy and chemotherapy using regimens containing platinum compound for primary intracranial germ cell tumors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 5-year progression-free survival
Key secondary outcomes 5-year overall survival, response rates, adverse events

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 Other
Interventions/Control_1 surgery
radiotherapy
chemotherapy
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
4 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Primary intracranial germ cell tumors excluding mature teratoma.
2.Histologically-confirmed intracranial germ cell tumors. If HCG>=2,000IU/ml and/or AFP>=2,000ng/ml, histology can be omitted.
3.The patient must not have any preceeding radiotherapy or chemotherapy.
4.Age>=4.
5.ECOG-PS of <3. PS=3 is allowed if the impairment is solely from neurological disturbance brought by tumors.
6.Hematologic, renal, hepatic, and cardiac status should be documented within one week before registration.
- White blood cell count >3,000 per mm3
- Absolute neutrophil count > 1,500 per mm3
- Platelets >80,000 per mm3
- Hemoglobin >10.0 grams
- AST and ALT < twice normal range
- Bilirubin < 1.5mg/dl
- Creatinine < 1.5mg/dl
- BUN <25mg/dl
- normal ECG
7. Therapy must begin < four weeks after surgery.
8. The patient must give written study-specific informed consent prior to study entry. If the patient is under 20 years old or the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member.
9. Patients must have an estimated survival of at least 12 weeks.

Key exclusion criteria 1. Previous malignancies.
2. Major renal, bladder, infectious illnesses, interstitial pneumonitis or pulmonary fibrosis, ischemic heart diseases, liver cirrhosis, bleeding, uncontrolled DM, or psychiatric impairments which in the investigator's opinion will prevent administration or completion of the protocol therapy.
3. Patients with known allergy to drugs used in the proposed regimens.
4. Patients taking warfarin.
5. patients pregnant or breast-feeding a baby.
6. Patients, in the investigator's opinion, cannot complete the protocol study.
Target sample size 210

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Matsutani
Organization International Medical Center, Saitama Medical University
Division name Dept. of Neurosurgery/Neuro-oncology
Zip code
Address 1397-1 Yamane, Hidaka-shi, Saitama 350-1298, Japan
TEL 042-984-4111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Nishikawa
Organization International Medical Center, Saitama Medical University
Division name Dept. of Neurosurgery/Neuro-oncology
Zip code
Address 1397-1 Yamane, Hidaka-shi, Saitama 350-1298, Japan
TEL 042-984-4111
Homepage URL
Email rnishika@saitama-med.ac.jp

Sponsor
Institute Organizing Committee for a phase 2 study of radio-chemotherapy for primary intracranial germ cell tumors
Institute
Department

Funding Source
Organization Gold Ribbon Network
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Development Organization for Frontier Medical Therapeutics
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 埼玉医科大学国際医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 15 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 Open public recruiting
Date of protocol fixation
2010 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2025 Year 12 Month 01 Day
Date of closure to data entry
2025 Year 12 Month 01 Day
Date trial data considered complete
2025 Year 12 Month 01 Day
Date analysis concluded
2025 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 09 Day
Last modified on
2010 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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