Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients

Official title

Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)

Overview

This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.

Detailed description

During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.

Interventions

• Radiation Ultra-fractionated radiation therapy
  5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.

Primary outcome measures

• The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree) [Time frame: until 12 weeks from the completion of postoperative radiotherapy]

Secondary outcome measures (8)

• Local recurrence rate [Time frame: Local recurrence rate would be recorded and reported until at least 5 years after diagnosis.]
• Local regional recurrence rate [Time frame: Local regional recurrence rate would be recorded and reported until at least 5 years after diagnosis.]
• Disease-free survival [Time frame: Until at least 5 years after diagnosis.]
• Overall survival [Time frame: Until at least 5 years after diagnosis.]
• The rate of patients who develop radiation-associated long-term toxicity [Time frame: From 12 weeks to 5 years post radiotherapy.]
• Quality of Life. [Time frame: European Organization Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC QLQ-C30 to record patients' quality of life before and at 12, 24 and 60 months after radiotherapy.]
• Quality of Life. [Time frame: The patients' quality of life will be evaluated before and at 12, 24 and 60 months after radiotherapy.]
• The cosmetic outcome. [Time frame: The cosmetic outcome will be evaluated before and at 12, 24 and 60 months after radiotherapy.]

Eligibility criteria

Inclusion criteria

• Patients diagnosed with invasive or non-invasive breast cancer;
• The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection;
• Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery).
• No distant metastasis;
• Life expectancy ≥6 months;
• Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.);
• Patients are willing to cooperate to follow up;
• Patients should sign the informed consent;
• Women of childbearing age need effective contraception.

Exclusion criteria

• Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.
• Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;
• Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;
• Concurrent active connective tissue disease;
• Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma);
• Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).
• Pregnant or breast-feeding.

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chine — Beijing

Identifiers

NCT: NCT05762900 · 22/409-3611

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗