A phase I/II clinical trial of radical radiotherapy using carbon-ion beams for early breast cancer

JRCT ID: jRCTs032180153

Registered date:25/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 19/07/2013
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Carbon ion radiotherapy 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 a day, four times in a week in principle. The dose was set as follows with reference to the results of clinical trials of four irradiations for stage I lung cancer.
Level 1 12.0 Gy (RBE) 4 times in a week 48.0 Gy (RBE)
Level 2 13.2 Gy (RBE) 4 times in a week 52.8 Gy (RBE)
Level 3 15.0 Gy (RBE) 4 times in a week 60.0 Gy (RBE)

Outcome(s)

Primary Outcome

1.Acute toxicities of normal tissue
2.Local control

Secondary Outcome

1. Local effect (CR rate)
2. Adverse reaction of normal tissue in late phase
3. Breast cosmetic outcomes
4. Progression-free survival period
5. Overall survival period

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Biopsy- or histology-proven invasive ductal carcinoma of the breast (usual type)
2. A single tumor with an extent of less than 2 cm on MRI (Stage I disease in UICC)
3. No extensive lymphatic infiltration (LVSI), no extensive intraductal extension (EIC). Estrogen receptor (ER) positive and HER2-negative.
4. PS is 0-2.
5. A woman age of 60 or over.
6. Expected to survive for more than 6 months.
7. The person wishes to participate in the exam and has obtained written consent.

Exclude criteria

1. Have serious uncontrollable complications (eg, uncontrollable cardiopulmonary disease, intractable infections, uncontrollable psychiatric disorders, etc.).
2. Has a history of treatment such as surgery, chemotherapy, endocrine therapy, and molecular-targeted drugs for ipsilateral breast cancer.
3. Systemic drug therapy for active cancers (including contralateral breast cancer).
4. Tumor infiltrates chest wall or skin.
5. The distance between the tumor and the skin, including the intraductal extension that can be identified on the MRI image, is within 5 mm.
6. There is a history of radiation therapy at the tumor site.
7. Ductal carcinoma in situ (pure DCIS).
8. The attending physician considers it inappropriate due to medical, psychological or other factors.

Related Information

• Primary Sponsor: Kobayashi Kana
• Secondary ID(s): UMIN000010848