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Trial Title:
Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients
NCT ID:
NCT05762900
Condition:
Breast Cancer
Radiotherapy Side Effect
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Ultra-fractionated radiotherapy
Toxicity
Lymph-drainage region irradiation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The treatment is not a drug.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Ultra-fractionated radiation therapy
Description:
5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.
Arm group label:
Ultra-hypofractionated arm
Other name:
Simultaneous Integrated Boost
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
35 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Jing, M.D.
Phone:
8610-87788281
Email:
owletskim@163.com
Start date:
October 25, 2022
Completion date:
October 25, 2030
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05762900
