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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000114
Receipt No. R000000165
Scientific Title The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306)
Date of disclosure of the study information 2005/09/05
Last modified on 2014/02/21

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Basic information
Public title The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306)
Acronym The safety and efficacy trial of primary chemo-radiotherapy for the early breast cancer (JCOG0306)
Scientific Title The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306)
Scientific Title:Acronym The safety and efficacy trial of primary chemo-radiotherapy for the early breast cancer (JCOG0306)
Region
Japan

Condition
Condition stage I to IIIA breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to investigate the safety and efficacy of primary chemo-radiotherapy for the early breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes pathological complete response rate
Key secondary outcomes toxicity, clinical complete response rate, breast conserving rate, relapse free survival, overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Doxorubicine+cyclophosphamide followed by paclitaxel, radiotherapy
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
70 years-old >=
Gender Female
Key inclusion criteria 1) Core needle biopsy-proven invasive breast cancer (female only)
2) Clinical stage I-IIIA
3) 5cm >= tumor diamiter confirmed by breast ultrasound sonography >= 2cm
4) All tumors exist within planning target volume of boost radiation, if multifocal lesions exist in the same breast
5) Patients without bilateral breast cancer
6) Age >= 20, <= 70
7) PS(ECOG) 0-1
8) Previously untreated with chemotherapy or radiotherapy
9) Adequate organ function
10) Written informed consent
Key exclusion criteria 1) Current history of malignant neoplasms except for curative carcinoma in situ or mucosal carsinoma
2) Pregnant or lactating women or women of childbearing potential
3) Active infectious diesase
4) Past histry of allergic reaction to cremophor EL(polyoxethylated castor oil) or polysorbate
5) Interstitial pneumonia or fibroid lung reveald by chest x-ray
6) Poorly controlled or insulin dependent diabetes mellitus
7) Psychological disease or psychological symptom that interferes with entering this trial
Target sample size 104

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Watanabe, MD , PhD
Organization Hamamatsu Oncology Center
Division name Medical Oncology
Zip code
Address 117 Shinmachi Hamamatsu, Shizuoka 430-0921, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Mukai, MD
Organization JCOG0306 Coordinating Office
Division name Divison of Oncology and Hematology, National Cancer Center Hospital East
Zip code
Address 6-5-1 kashiwahoha, Kashiwa-shi, Chiba, 277-8577, Japan
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group
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 国立病院機構北海道がんセンター(北海道)
栃木県立がんセンター(栃木県)
自治医科大学附属病院(栃木県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
東京医科大学病院(東京都)
がん・感染症センター都立駒込病院(東京都)
国立病院機構東京医療センター(東京都)
慶応義塾大学病院(東京都)
聖路加国際病院(東京都)
東海大学医学部(神奈川県)
神奈川県立がんセンター(神奈川県)
北里大学医学部(神奈川県)
横浜労災病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
静岡県立総合病院(静岡県)
愛知県がんセンター中央病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
近畿大学医学部(大阪府)
国立病院機構大阪医療センター(大阪府)
川崎医科大学(岡山県)
国立病院機構呉医療センター・中国がんセンター(広島県)
国立病院機構福山医療センター(広島県)
広島市立安佐市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
北九州市立医療センター(福岡県)
国立病院機構長崎医療センター(長崎県)

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24247597
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 05 Month 13 Day
Date of IRB
Anticipated trial start date
2004 Year 07 Month 01 Day
Last follow-up date
2009 Year 10 Month 01 Day
Date of closure to data entry
2009 Year 10 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2009 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 05 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=R000000165

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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