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


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 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


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

Value
https://center6.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