Unique ID issued by UMIN | C000000114 |
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Receipt number | 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 14:12:04 |
The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306)
The safety and efficacy trial of primary chemo-radiotherapy for the early breast cancer (JCOG0306)
The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306)
The safety and efficacy trial of primary chemo-radiotherapy for the early breast cancer (JCOG0306)
Japan |
stage I to IIIA breast cancer
Breast surgery |
Malignancy
NO
to investigate the safety and efficacy of primary chemo-radiotherapy for the early breast cancer
Safety,Efficacy
Exploratory
Phase II
pathological complete response rate
toxicity, clinical complete response rate, breast conserving rate, relapse free survival, overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
Doxorubicine+cyclophosphamide followed by paclitaxel, radiotherapy
20 | years-old | <= |
70 | years-old | >= |
Female
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
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
104
1st name | |
Middle name | |
Last name | Toru Watanabe, MD , PhD |
Hamamatsu Oncology Center
Medical Oncology
117 Shinmachi Hamamatsu, Shizuoka 430-0921, Japan
1st name | |
Middle name | |
Last name | Hirofumi Mukai, MD |
JCOG0306 Coordinating Office
Divison of Oncology and Hematology, National Cancer Center Hospital East
6-5-1 kashiwahoha, Kashiwa-shi, Chiba, 277-8577, Japan
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare
Japan
NO
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)
2005 | Year | 09 | Month | 05 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/24247597
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
Completed
2004 | Year | 05 | Month | 13 | Day |
2004 | Year | 07 | Month | 01 | Day |
2009 | Year | 10 | Month | 01 | Day |
2009 | Year | 10 | Month | 01 | Day |
2009 | Year | 10 | Month | 01 | Day |
2009 | Year | 10 | Month | 01 | Day |
2005 | Year | 09 | Month | 05 | Day |
2014 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000165
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