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Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer

ConditionsEarly Breast CancerDuctal Breast Carcinoma In Situ
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-85
SponsorNational Taiwan University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

Pregnant patients

Patients requiring re-irradiation of the thoracic region

Trial population

Female patients diagnosed with early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS) who are undergoing breast-conserving surgery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hypofractionated Radiation Therapy

    Radiation

    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

Treatment groups

315 Participants
are divided into 1 treatment group
Group A: CBB1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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