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The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton therapy | Experimental | Proton radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer. |
|
| photon therapy | Active Comparator | Photon radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiotherapy | Radiation | Lumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years | We will record the incidence of ≥ 2 degree radiation-associated toxicity, such as breast or chest wall oedema, dermatitis, breast pain, esophagitis, rib fracture, radiation pneumonia and hypothyroidism and so on. The incidence of all the above is the primary outcome. | Until 2 years after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicities after 2 years of radiotherapy | Evaluation of long-term adverse effects (greater than 2 years) after radiotherapy (including radiation pulmonary fibrosis, radiation skin fibrosis, rib fracture, brachial plexus injury, upper limb lymphedema, heart injury, hypothyroidism, etc.) | Until 5 years after radiotherapy |
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Inclusion Criteria:
Histologically confirmed invasive breast cancer.
Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine/targeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall/breast and regional lymphatic drainage areas.
No distant metastasis.
Age range: 18-80 years.
Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-2.
Non-pregnant and non-lactating women.
Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.
Exclusion Criteria:
Presence of Ductal Carcinoma In Situ (DCIS).
Tumor staging: Patients presenting with T4, N0, or N3c disease.
History of prior radiotherapy to the ipsilateral chest or breast.
Surgical margin status: Margins are either positive or close, defined as:
Invasive carcinoma within 1 mm of the surgical margin.
Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Li, M.D. | Contact | 021-38296666 | ping.li@sphic.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Photon radiotherapy | Radiation | Lumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week. |
|
| Locoregional recurrence (LRR) |
To estimate and compare the rate of local recurrence between the proton and photon arms |
| Until 5 years after treatment. |
| Disease-free survival (DFS) | Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up. | Until 5 years after treatment. |
| Overall survival (OS) | Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up. | Until 5 years after treatment. |
| uality of life, as measured by EORTC Quality of Life Questionnaires-B23 | Impact on quality of life will be assessed by EORTC Quality of Life Questionnaires-B23ï¼›Which include functional domains, global health status and symptom scales. | During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy |
| Cosmetic outcome | photographic cosmetic scores by BCCT.core | Until 5 years after treatment. |
| D017437 |
| Skin and Connective Tissue Diseases |