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This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.
During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-hypofractionated arm | Experimental | The patients will be treated by Ultra-hypofractionated irradiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-fractionated radiation therapy | Radiation | 5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree) | The investigators will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin; ≥ 3 degree radiation-associated esophagitis; ≥ 3 degree radiation-associated lymphopenia. | until 12 weeks from the completion of postoperative radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence rate | The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast or chest wall. | Local recurrence rate would be recorded and reported until at least 5 years after diagnosis. |
| Local regional recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu-Lian Wang, M.D. | Contact | 8610-87788290 | wangsl@cicams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | 100021 | China |
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The treatment is not a drug.
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The incidence of recurrence in the ipsilateral breast/chest wall or the lymphatic nodal regions. |
| Local regional recurrence rate would be recorded and reported until at least 5 years after diagnosis. |
| Disease-free survival | The time interval from diagnosis to any event of recurrence or death. | Until at least 5 years after diagnosis. |
| Overall survival | The time interval from diagnosis to death from any reason. | Until at least 5 years after diagnosis. |
| The rate of patients who develop radiation-associated long-term toxicity | The investigators will record the incidence of any long-term toxicities, such as skin or subcutaneous fibrosis, pain, breast distortion, brachial plexopathy, lymphodema, cardiac event, rib fracture, pulmonary fibrosis, and so on. | From 12 weeks to 5 years post radiotherapy. |
| Quality of Life. | European Organization for Research and Treatment of Cancer General Quality of Life Questionnaire (brev: EORTC C-30) is used. The higher the score, the worse the situation, with the range of 28 to 112. | European Organization Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC QLQ-C30 to record patients' quality of life before and at 12, 24 and 60 months after radiotherapy. |
| Quality of Life. | European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (brev: EORTC BR-23) is used. The higher the score, the worse the situation, with the range of 23 to 92. | The patients' quality of life will be evaluated before and at 12, 24 and 60 months after radiotherapy. |
| The cosmetic outcome. | Breast Cancer Treatment Outcome Scale 22 (brev: BCTOS 22) is used, for patients who receive breast conservative surgery. The higher the score, the worse the cosmesis, with the range of 22 to 88. | The cosmetic outcome will be evaluated before and at 12, 24 and 60 months after radiotherapy. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
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