Adjuvant Radiotherapy, Breast Cancer, Surgery
Conditions
Brief summary
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.
Detailed description
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)
Interventions
Hypofractionation with simultaneous integrated boost
Sponsors
Capital Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins * Indication to adjuvant radiotherapy including boost radiotherapy * Clearly identified primary tumor region preferably by radiopaque clips * Primary wound healing after breast conserving therapy without signs of infection * Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated * Written informed consent
Exclusion criteria
* Patients operated by mastectomy * No indication for boost radiation * Resection margins positive for disease or insufficient identification of the boost volume * Indication for radiotherapy of the regional lymph nodes * History of prior breast or thoracic radiotherapy * Extended postoperative seroma at the beginning of radiotherapy * Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance * Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Toxicity | 6 months | Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the radiation plan | 19 days | Dose constraints Dmean lung \< 10 Gy; Dmean heart \< 5 Gy, Dmedian contralateral breast \< 4Gy |
| other acute Toxicity | 0-6 months | All dimensions of NCI-CTCAE/RTOG |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWenjie Ni, MD.
Beijing Shijitan Hospital, Capital Medical University
Outcome results
None listed