UMIN-CTR Clinical Trial

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

stage I to IIIA breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

pathological complete response rate

Key secondary outcomes

toxicity, clinical complete response rate, breast conserving rate, relapse free survival, overall survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Clinical Oncology Group

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2005

Year

09

Month

05

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2005

Year

09

Month

05

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=R000000165