UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010472 |
|---|---|
| Receipt number | R000012087 |
| Scientific Title | Phase II trial of polifeprosan 20 with carmustine implant , Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas |
| Date of disclosure of the study information | 2013/04/12 |
| Last modified on | 2013/08/01 15:40:24 |
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Basic information
Public title
Phase II trial of polifeprosan 20 with carmustine implant , Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas
Acronym
Phase II trial of polifeprosan 20 with carmustine implant , Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas
Scientific Title
Phase II trial of polifeprosan 20 with carmustine implant , Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas
Scientific Title:Acronym
Phase II trial of polifeprosan 20 with carmustine implant , Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas
Region
| Japan |
Condition
Condition
glioblastoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate efficacy and safety of interferon-beta,temozolomide and polifeprosan 20 with carmustine implant with radiotherapy for newly diagnosed glioblastoma.
Based on the result of this trial, we determine whether interferon-beta,temozolomide and polifeprosan 20 with carmustine implant with radiotherapy is worth proceeding to the subsequent phase III trial or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year survival rate
Key secondary outcomes
overall survival
progression free survival
response rate
adverse event
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Place polifeprosan 20 with carmustine implant on the tumor cavity during the operation.
Initial therapy(temozolomide+IFN beta+radiation ) starts within 21 days after the operation.
Maintenance therapy(temozolomide+IFN beta)starts 28days after completion of initial treatment.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)suspicion of glioblastoma
2)Supratentorial tumor on preoperative MRI.
3)No tumor recognized in the optic nerve, olfactory nerve and pituitary gland on preoperative MRI.
4)No multiple legions or dissemination recognized on preoperative MRI
5)Planning target volume (irradiated 60Gy) is less than 1/3 of the brain volume
6)Aged 20 to 75 years old
7)ECOG performance status of 0,1 or 3 due to neurological signs caused by the tumor
8)No prior chemotherapy or radiation therapy for any malignant diseases
9)Sufficient organ functions
10)Written informed consent
Key exclusion criteria
1)Simultaneous or metachronous (within the past 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
2)Infection with systemic therapy indicated
3)fever over 38 degrees Celsius
4)Active infectious meningitis
5)Women during pregnancy, possible pregnancy or breast-feeding
6)Psychosis
7)Uncontrollable diabetes mellitus or administration of insulin
8)Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
9)Interstitial pneumonia, or fibroid lung
10)Patients who can 't receive gadolinium
11)drug contraindication to use (carmustine, interferon beta, of temozolomide).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Natsume |
Organization
Nagoya University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
TEL
052-741-2111
Homepage URL
Sponsor or person
Institute
Department of Neurosurgery,Nagoya University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 04 | Month | 12 | 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
| 2013 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 11 | Day |
Last modified on
| 2013 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012087
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| Registered date | File name |
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