Breast cancer patients stage II-III aged 18 years or older who undergo breast conserving surgery with free surgical margins from both invasive carcinoma and ductal carcinoma in situ (DCIS) and are planned to receive whole breast radiation with tumor bed boost with or without regional lymph node radiation. Ultrahypofractionation, moderated hypofractionation, breast cancer, radiotherapy
Conditions
Interventions
The participants in MHF-SIB group will be treated with daily dosage of moderated hypofractionation
radiotherapy for 16 fractions. The prescribed dose for the CTV breast and CTV LN is 42.4 Gy (2.65
Gy/
moderate hypofractionation with SIB boost (MHF-SIB) ,ultra-hypofractionation with SIB boost (UHF-SIB)
Sponsors
Pitchayaponne Klunklin
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Capable of giving written informed consent (2) Female with age 18 years or older at the time of signing the ICF (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment (4) Histologically documented breast cancer stage II-III according to the American Joint Committee on Cancer (AJCC) cancer staging 8th edition (5) Undergo breast conserving surgery with free surgical margins from both invasive carcinoma and ductal carcinoma in situ (DCIS) (6) Whole breast radiation with tumor bed boost with or without regional lymph node radiation planned (7) Neoadjuvant and adjuvant systemic treatments are permitted according to standard treatment guidelines
Exclusion criteria
Exclusion criteria: (1) Patients received mastectomy (2) Not suitable for tumor bed boost radiation (Meet all criteria: age >50, low grade) (3) Bilateral breast cancer (4) pregnancy or women of childbearing potential (5) History of prior breast or thoracic radiotherapy (6) History of another primary malignancy unless disease is free for a minimum of 5 years prior to enrollment (7) Any medical conditions or comorbidities that may prevent the patient from receiving radiotherapy according to protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute skin toxicity within 3 months 3 months after radiation RTOG/EORTC acute and late radiation morbidity criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year late skin and subcutaneous toxicity 2 years RTOG/EORTC acute and late radiation morbidity criteria,2-year ipsilateral local recurrence rate 2 years Case record form,2-year late shoulder-joint toxicity 2 years RTOG/EORTC acute and late radiation morbidity criteria,2-year lymphedema rate 2 years International Society of Lymphology (ISL) | — |
Countries
Thailand
Contacts
Public ContactPitchayaponne Klunklin
Faculty of Medicine, Chiangmai University
Outcome results
None listed