UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003466 |
|---|---|
| Receipt number | R000004191 |
| Scientific Title | A Multicenter Randomized Phase II trial of Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas(JCOG0911, INTEGRA study (P-II)) |
| Date of disclosure of the study information | 2010/04/09 |
| Last modified on | 2013/04/18 14:09:42 |
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Basic information
Public title
A Multicenter Randomized Phase II trial of Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas(JCOG0911, INTEGRA study (P-II))
Acronym
A Multicenter Randomized Phase II trial of Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas(JCOG0911, INTEGRA study (P-II))
Scientific Title
A Multicenter Randomized Phase II trial of Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas(JCOG0911, INTEGRA study (P-II))
Scientific Title:Acronym
A Multicenter Randomized Phase II trial of Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas(JCOG0911, INTEGRA study (P-II))
Region
| Japan |
Condition
Condition
Glioblastoma
Classification by specialty
| Radiology | 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 plus temozolomide with radiotherapy for newly diagnosed glioblastoma, comparing to temozolomide with radiotherapy. Based on the result of this trial, we determine whether interferon-beta plus temozolomide with radiotherapy is worth proceeding to the subsequent phase III trial or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
progression-free survival, complete response rate, response rate, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A:
Initial therapy:
temozolomide (75mg/m2/day, administered orally everyday from the first day to the last day of radiotherapy) with radiotherapy (60 Gy/30 fr, 5 days/week)
Maintenance therapy:
temozolomide (100-200mg/m2, day1-5), every 4 weeks
Interventions/Control_2
B:
Initial therapy:
temozolomide (75mg/m2/day, administered orally everyday from the first day to the last day of radiotherapy) plus IFN-beta (3 MIU/body/day, administered intravenously 3 days/week during radiotherapy) with radiotherapy (60 Gy/30 fr, 5 days/week)
Maintenance therapy:
temozolomide (100-200mg/m2/day, day2-6, every 4 weeks) plus IFN-beta (3 MIU/body, day1), every 4 weeks
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) Histologically proven 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) Three to 20 days after surgery for glioblastoma (removal or biopsy)
7) Aged 20 to 75 years old
8) ECOG performance status of 0,1 or 3 due to neurological signs caused by the tumor
9) No prior chemotherapy or radiation therapy for any malignant diseases
10) Sufficient organ functions
11) 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
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Wakabayashi |
Organization
Nagoya University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Natsume |
Organization
JCOG0911 Coordinating Office
Division name
Department of Neurosurgery, Nagoya University School of Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2355
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
北海道大学病院（北海道）
中村記念病院（北海道）
札幌医科大学（北海道）
岩手医科大学（岩手県）
東北大学病院（宮城県）
山形大学医学部（山形県）
筑波大学臨床医学系（茨城県）
埼玉医科大学国際医療センター（埼玉県）
千葉大学医学部（千葉県）
国立がん研究センター中央病院（東京都）
杏林大学医学部（東京都）
東京女子医科大学（東京都）
慶應義塾大学病院（東京都）
東京大学医学部（東京都）
聖マリアンナ医科大学（神奈川県）
名古屋大学医学部（愛知県）
京都大学医学部附属病院（京都府）
大阪大学医学部（大阪府）
田附興風会医学研究所北野病院（大阪府）
関西医科大学附属枚方病院（大阪府）
広島大学病院（広島県）
愛媛大学医学部附属病院（愛媛県）
久留米大学医学部（福岡県）
熊本大学医学部（熊本県）
大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 09 | 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
| 2010 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | 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
| 2010 | Year | 04 | Month | 09 | Day |
Last modified on
| 2013 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004191
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