UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter safety trial of hypofractionated radiation therapy after breast-conserving surgery: CONBAT trial (JCOG0906)
Acronym	Multicenter safety trial of hypofractionated radiation therapy after breast-conserving surgery: CONBAT trial (JCOG0906)
Scientific Title	Multicenter safety trial of hypofractionated radiation therapy after breast-conserving surgery: CONBAT trial (JCOG0906)
Scientific Title:Acronym	Multicenter safety trial of hypofractionated radiation therapy after breast-conserving surgery: CONBAT trial (JCOG0906)
Region	Japan

Condition
Condition	breast cancer after breast-conserving surgery
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To confirm the safety of hypofractionated radiation therapy after breast-conserving surgery in patients with margin-negative invasive breast cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Proportion of grade 2 or more late adverse reactions at 3 years
Key secondary outcomes	overall survival, disease-free survival, ipsilateral breast recurrence-free survival, proportion of treatment completion in specific term, acute adverse events, proportion of deterioration of breast cosmetic outcomes, proportion of grade 2 or more late adverse reactions at 5 years

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	Maneuver
Interventions/Control_1	Hypofractionated radiation therapy (42.56 Gy/ 16 fr/ 22 days) for whole breast. For patients with close margin, boost irradiation (10.64 Gy/ 4 fr/ 4 days) was added.
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	75 years-old >=
Gender	Female
Key inclusion criteria	1) Preoperative status fulfills all of the following conditions: i) single primary tumor, ii) tumor size 3 cm or less, iii) no distant metastasis, iv) no prior chemotherapy or hormonal therapy. 2) Intra- and Postoperative status fulfills all of the following conditions: i) breast-conserving surgery with lumpectomy or segmental mastectomy (endscopic surgery is excluded), ii) axillary lymph node dissection with level I or II, or histologically negative sentinel lymph nodes, iii) no simultaneous breast reconstruction, v) no ongoing treatments for postoperative complications. 3) Pathological findings fulfills all of the following conditions: i) invasive carcinoma, ii) three or less positive axillary lymph nodes, or histologically negative sentinel lymph nodes, iii) no tumor exposure to excision margin. 4) Adjuvant chemotherapy with anthracyclines or taxanes (only in case with high-risk factors). 5) Within 70 days from surgery in case without adjuvant chemotherapy, and within 28 days from the latest chemotherapy in case with adjuvant chemotherapy. 6) Asian woman with enough fluency in Japanese. 7) Aged 20 to 75 years old. 8) Performance status of 0 or 1. 9) No prior radiation therapy against the thoracic. 10) Sufficient organ functions. 11) Written informed consent.
Key exclusion criteria	1) Simultaneous or metachronous (within 5 years) double cancers. 2) Infection with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Women during pregnancy, possible pregnancy or breast-feeding. 5) Psychosis. 6) Uncontrollable diabetes mellitus or administration of insulin. 7) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 8) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis. 9) Systemic steroids medication. 10) immunosuppressant for active collagen disease. 11) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.
Target sample size	310

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshikazu Kagami
Organization	National Cancer Center Hospital
Division name	Radiation Oncology Division
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL	03-3542-2511
Email

Public contact
Name of contact person	1st name Middle name Last name Miwako Nozaki
Organization	JCOG0906 Coordinating Office
Division name	Department of Radiology, Dokkyo Medical University Koshigaya Hospital
Zip code
Address	2-1-50, Minami-Koshigaya, Koshigaya, Saitama, 343-8555, JAPAN
TEL	048-965-1111
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
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

札幌医科大学（北海道） 東北大学病院（宮城県） 栃木県立がんセンター（栃木県） 埼玉県立がんセンター（埼玉県） 獨協医科大学越谷病院（埼玉県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 千葉大学医学部（千葉県） 国立がん研究センター中央病院（東京都） がん・感染症センター都立駒込病院（東京都） 東京女子医科大学（東京都） 慶應義塾大学病院（東京都） がん研究会有明病院（東京都） 東京大学医学部（東京都） 北里大学医学部（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 山梨大学医学部（山梨県） 信州大学医学部（長野県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 京都大学医学部附属病院（京都府） 大阪大学医学部（大阪府） 近畿大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 大阪市立総合医療センター（大阪府） 兵庫県立がんセンター（兵庫県） 先端医療センター（兵庫県） 広島大学病院（広島県） 国立病院機構四国がんセンター（愛媛県） 九州大学病院（福岡県） 琉球大学医学部（沖縄県）

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2009 Year 12 Month 08 Day
Date of IRB	2010 Year 02 Month 12 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2016 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 02 Month 17 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003679