UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004528 |
|---|---|
| Receipt number | 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 14:08:44 |
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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
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
rnishika@saitama-med.ac.jp
Sponsor or person
Institute
Organizing Committee for a phase 2 study of radio-chemotherapy for primary intracranial germ cell tumors
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005381
