Ductal Breast Carcinoma In Situ, Early Breast Cancer
Conditions
Keywords
breast cancer, concomitant boost, tumor bed, Intensity-modulated radiation therapy, hypofractionated breast radiotherapy
Brief summary
Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy
Interventions
RADIATIONHypofractionated Radiation Therapy
Hypofractionated breast radiotherapy (HFRT) with hybrid techniques combining field-in-field intensity-modulated RT (FIF-IMRT) to the whole breast with inverse-IMRT for concomitant boost
Sponsors
National Taiwan University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Female patients with histologically confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS). * Patients undergoing breast-conserving surgery * Age ≥ 20 years * Karnofsky Performance Status (KPS) ≥70% * Life expectancy ≥ 5 years * Adequate renal and hepatic function
Exclusion criteria
* Pregnant patients * Patients requiring re-irradiation of the thoracic region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral breast tumor recurrence | From enrollment to the end of treatment at 2 years | The time from the date of completion of radiotherapy to the date of ipsilateral breast recurrence or death, whichever occurs first. Unit of Measure: Time-to-event (months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Phase Acute Skin Toxicity | Up to 3 months following completion of radiotherapy | Acute skin toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5) |
| Late Phase Breast Fibrosis | From 3 months up to 5 years following completion of radiotherapy | Late breast fibrosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5) |
| Patient Quality of Life (EORTC QLQ-C30) | At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years) | Quality of life evaluation using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100) |
| Patient Quality of Life (EORTC QLQ-BR23) | At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years) | Quality of life evaluation using the Breast Cancer Module (BR23) of the European Organization for Research and Treatment of Cancer, Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100) |
Countries
Taiwan
Contacts
Primary ContactYen-Ting Liu
Outcome results
None listed