UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000108 |
|---|---|
| Receipt number | R000000158 |
| Scientific Title | A randomized phase II/III study of ACNU versus Procarbazine plus ACNU as a postoperative chemoradiotherapy for strocytoma grade 3 and 4(JCOG0305, ACNU+PCZ PhaseII/III) |
| Date of disclosure of the study information | 2005/09/02 |
| Last modified on | 2014/02/21 14:09:37 |
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Basic information
Public title
A randomized phase II/III study of ACNU versus Procarbazine plus ACNU as a postoperative chemoradiotherapy for strocytoma grade 3 and 4(JCOG0305, ACNU+PCZ PhaseII/III)
Acronym
A randomized phase II/III study of ACNU versus Procarbazine plus ACNU as a postoperative chemoradiotherapy for astrocytoma grade 3 and 4(JCOG0305, ACNU+PCZ PhaseII/III)
Scientific Title
A randomized phase II/III study of ACNU versus Procarbazine plus ACNU as a postoperative chemoradiotherapy for strocytoma grade 3 and 4(JCOG0305, ACNU+PCZ PhaseII/III)
Scientific Title:Acronym
A randomized phase II/III study of ACNU versus Procarbazine plus ACNU as a postoperative chemoradiotherapy for astrocytoma grade 3 and 4(JCOG0305, ACNU+PCZ PhaseII/III)
Region
| Japan |
Condition
Condition
astrocytoma grade 3/4
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of postoperative chemoradiotherapy with ACNU and procarbazine for astrocytoma grade 3/4 compared to that with ACNU
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
Endpoint in phase II stage:
6 months survival
Endpoint in phase III stage:
Overall survival (OS)
Key secondary outcomes
Endpoint in phase II stage:
Overall survival (OS)
Endpoint in phase III stage:
Progression free survival (PFS) ,Response rate (RR), % complete response (%CR),Toxicity
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 | Maneuver |
Interventions/Control_1
A: RT+ACNU
Interventions/Control_2
B: RT+Procarbazine+ACNU
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven astrocytoma grade 3 or 4
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 14 days after surgery for astrocytoma (removal or biopsy)
7. Age 20-69 y.o.
8. ECOG performance status (PS) 0,1,2 or 3 due to neurological signs caused by the tumor
9. Initial treatment for astrocytoma grade 3 or 4
10. No prior radiotherapy or chemotherapy for cancers including other organs
11. Lab data as follows
WBC >= 3,000/mm3
Hemogllobin >= 8.0g/dl
Platelet >= 100,000/mm3
creatinine <= 1.5mg/dl
GOT <= 100 IU
GPT <= 100 IU
12. Written informed consent
Key exclusion criteria
1. Synchronous double cancer or metachronous double cancer in last 5 years; carcinoma in situ accepted
2. Meningitis or pneumonia
3. Pregnant, possibly pregnant or nursing women
4. Mental disorder
5. Uncontrollable diabetes mellitus or DM under treatment with Insulin
6. Myocardial infarction in last 3 months
7. History of pulmonary fibrosis or interstitial pneumonia
Target sample size
310
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichiro Shibui, MD, DMSc |
Organization
National Cancer Center Hospital
Division name
Neurosurgery Division
Zip code
Address
5-1-1 Tukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichiro Shibui, MD, DMSc |
Organization
JCOG0305 Coordinating Office
Division name
Neurosurgery Division, National Cancer Center Hospital
Zip code
Address
5-1-1 Tukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
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）
埼玉医科大学病院（埼玉県）
国立がんセンター中央病院（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）
熊本大学医学部（熊本県）
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23228988
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
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
Completed
Date of protocol fixation
| 2004 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 09 | 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
| 2005 | Year | 09 | Month | 02 | Day |
Last modified on
| 2014 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000158
