UMIN-CTR Clinical Trial

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

Contact us.