NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032200066

Registered date:09/07/2020

Breast III

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment03/12/2020
Target sample size45
Countries of recruitment
Study typeInterventional
Intervention(s)Carbon-ion radiotherapy (C-ion RT) is performed using medical heavy particle accelerator (HIMAC) installed at National Institute of Radiological Sciences. The irradiation range includes the tumor identified by MRI with surrounding microscopic tumor, but not includes skin. Position verification is performed by referring to metal markers. The irradiation is performed using breathing synchronous system. The irradiation is done once. After the C-ion RT, adjuvant therapy is performed according to the Breast Cancer Care Guidelines of the Japanese Breast Cancer Society.

Outcome(s)

Primary OutcomeIn phase I: Acute toxicities of normal tissue Evaluation of dose limitting toxicities In phase II: Preliminary local effect (non-PD rate)
Secondary OutcomeIn phase I: Adverse reaction of normal tissue in late phase Preliminary local effect (non-PD rate) Breast cosmetic outcomes QOL at 2 years after the treatment In phase II: Adverse reaction of normal tissue in acute phase Adverse reaction of normal tissue in late phase Local control rate at 2 years Breast cosmetic outcomes Progression-free survival period Overall survival period QOL at 2 years after the treatment

Key inclusion & exclusion criteria

Age minimum>= 50age old
Age maximumNot applicable
GenderFemale
Include criteria1.Pathologically proven ductal carcinoma in situ or invasive ductal carcinoma (usual type) 2.Single lesion, tumor 2 cm or less on MRI: which is classified as Stage 0-I (UICC) 3.No lymphovascular space involvement, no extensive intraductal carcinoma 4.Luminal A like sub type (in case the patient has IDC) 5.Performance status 0 to 2 6.Age 50 years old and over 7.No other life-threatening illness 8.Written informed consent with
Exclude criteria1.Severe complication 2.Previous treatment 3.Active double primary 4.Tumor invasion to skin or chest wall 5.Distance between tumor border to skin less than 5mm 6.Previous irradiation at tumor site 7.Medically, psychologically or other reason who are not suitable for candidate

Related Information

Contact

Public contact
Name Kazutoshi Murata
Address 4-9-1 Anagawa Inage-ku, Chiba-shi, Chiba, Japan Chiba Japan 263-8555
Telephone +81-43-206-3306
E-mail okonogi.noriyuki@qst.go.jp
Affiliation QST Hospital, National Institutes for Quantum Science and Technology
Scientific contact
Name Kumiko Karasawa
Address 4-9-1 Anagawa Inage-ku, Chiba-shi, Chiba, Japan Chiba Japan 263-8555
Telephone +81-43-206-3306
E-mail kkarasawa@gmail.com
Affiliation QST Hospital, National Institutes for Quantum Science and Technology