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| Name | Class |
|---|---|
| Liaoning Cancer Hospital & Institute | OTHER |
| Wuhan University | OTHER |
| China-Japan Union Hospital, Jilin University | OTHER |
| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University |
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More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. >2), hormone receptor(positive vs. negative). SBRT technique is preferred. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control arm | Active Comparator | standard of care |
|
| study arm | Experimental | radiotherapy + standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care | Drug | patients receive appropriate therapy at the discretion of the treating oncologist, i.e. systemic therapy according to molecular subtypes, including chemotherapy, endocrine therapy, targeted therapy, or immunotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Time from randomization to disease progression at any site or death. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from randomization to death from any cause. | 2 years |
| Local control rate | Incidence of tumor control within RT fields during follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu-lian Wang, M.D | Contact | 8610-87788803 | wangsl@cicams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shu-lian Wang, M.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | 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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
| West China Hospital | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
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| radiotherapy + standard of care | Radiation | Patients receive radiotherapy to all known metastases. SBRT technique is preferred, especially for metastases in bone, lung and liver. Conventional RT can be used when SBRT is not appropriate, such as metastasis in mediastinal or contralateral supraclavicular nodal regions. Total doses of 30Gy to 50Gy in 5 fractions for SBRT are recommended depending on the tolerance of adjacent normal tissue. Total dose of 60Gy in 25 fractions is recommended for conventional RT. Patients can receive systemic therapy concurrently with RT at the discretion of treating radiation oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist. |
|
| 2 years |
| Incidence of toxicities | Incidence of acute and late toxicities from treatment graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 4.0 | 2 years |
| Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G) | Assessment of quality of life scores by FACT-G | 2 years |
| Translational exploration | Assessment of circulating tumor cells (CTCs), ctDNA, as prognostic and predictive markers of survival, and for early detection of progression. | 2 years |
| Proportion of acceptable SBRT completion | Proportion of patients who completed SBRT with acceptable dose prescriptions | 2 years |
| Wei-Fang Yang | Recruiting | Taizhou | Zhejiang | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D013812 | Therapeutics |