Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer

National Taiwan University Hospital315 enrolled

Overview

Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy

Study Type

OBSERVATIONAL

Enrollment

315

Conditions

Early Breast Cancer Ductal Breast Carcinoma In Situ

Interventions

Hypofractionated Radiation TherapyRADIATION

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

NOT_YET_RECRUITING

National Taiwan University Hospital Yunlin Branch

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Ipsilateral breast tumor recurrence

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)

Time frame: From enrollment to the end of treatment at 2 years

Secondary Outcomes

Early Phase Acute Skin Toxicity

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)

Time frame: Up to 3 months following completion of radiotherapy

Late Phase Breast Fibrosis

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)

Time frame: From 3 months up to 5 years following completion of radiotherapy

Patient Quality of Life (EORTC QLQ-C30)

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)

Time frame: 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)

Patient Quality of Life (EORTC QLQ-BR23)

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)

Time frame: 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)

Central Contacts

Yen-Ting Liu

CONTACT

88697255451 nickliucool@ntuh.gov.tw

Data from ClinicalTrials.gov

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