Breast III

JRCT ID: jRCTs032200066

Registered date:09/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 03/12/2020
• Target sample size: 45
• Study type: Interventional
• 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 Outcome

In phase I:
Acute toxicities of normal tissue
Evaluation of dose limitting toxicities
In phase II:
Preliminary local effect (non-PD rate)

Secondary Outcome

In 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 maximum: Not applicable
• Gender: Female

Include criteria

1.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 criteria

1.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

• Primary Sponsor: Kobayashi Kana