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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000108
Receipt No. 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

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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
Email

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/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000158

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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