![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | stage I to IIIA breast cancer | |
Classification by specialty |
|
|
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 |
|
||
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
Organization | Hamamatsu Oncology Center | ||||||
Division name | Medical Oncology | ||||||
Zip code | |||||||
Address | 117 Shinmachi Hamamatsu, Shizuoka 430-0921, Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
|
||||||
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/ | ||||||
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |