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Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.
Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.
Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionation with SIB | Experimental | Hypofractionation with SIB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionation with simultaneous integrated boost | Radiation | Hypofractionation with simultaneous integrated boost |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity | Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the radiation plan | Dose constraints Dmean lung < 10 Gy; Dmean heart < 5 Gy, Dmedian contralateral breast < 4Gy | 19 days |
| other acute Toxicity | All dimensions of NCI-CTCAE/RTOG |
| Measure | Description | Time Frame |
|---|---|---|
| Skin toxicity (Cosmetic results) | RTOG | 0 to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenjie Ni, MD. | Beijing Shijitan Hospital, Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital | Beijing | 100038 | China |
No.
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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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| 0-6 months |
| D017437 |
| Skin and Connective Tissue Diseases |