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Recruiting NCT06984250

Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer

— Observational Early Breast Cancer Ductal Breast Carcinoma In Situ

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypofractionated Radiation Therapy.
Who it may be relevant to
Registry conditions: Early Breast Cancer, Ductal Breast Carcinoma In Situ. Basic parameters: 20 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Hybrid Techniques Combining Hypofractionated Whole Breast Radiotherapy With Concomitant Tumor Bed Boost in Patients With Breast Cancer

Overview

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

Interventions

  • Radiation Hypofractionated 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

Primary outcome measures

  • Ipsilateral breast tumor recurrence [Time frame: From enrollment to the end of treatment at 2 years]
Secondary outcome measures (4)
  • Early Phase Acute Skin Toxicity [Time frame: Up to 3 months following completion of radiotherapy]
  • Late Phase Breast Fibrosis [Time frame: From 3 months up to 5 years following completion of radiotherapy]
  • Patient Quality of Life (EORTC QLQ-C30) [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) [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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 2 centers
  • National Taiwan University Hospital — Taipei
  • National Taiwan University Hospital Yunlin Branch — Taipei

Identifiers

NCT: NCT06984250 · 202110027RINB · 113-S0087

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗