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Clinical Trials in China / NCT05762900
Recruiting Phase 2

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

NCT05762900 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 2
Started
2022-10-25
Last updated
2023-03-10

Condition(s) studied

Breast CancerRadiotherapy Side Effect

Investigational drug(s) / intervention(s)

Ultra-fractionated radiation therapy

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

Study summary

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.

Eligibility

Sex
FEMALE
Min age
35 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Patients diagnosed with invasive or non-invasive breast cancer; 2. The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection; 3. Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery). 4. No distant metastasis; 5. Life expectancy ≥6 months; 6. 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.); 7. Patients are willing to cooperate to follow up; 8. Patients should sign the informed consent; 9. Women of childbearing age need effective contraception. Exclusion Criteria: 1. Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement. 2. Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury; 3. Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before; 4. Concurrent active connective tissue disease; 5. 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); 6. 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). 7. Pregnant or breast-feeding.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China Recruiting

More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05762900 on ClinicalTrials.gov ↗ ← All trials in China