Comparing two types of radiotherapy after breast conserving surgery for breast cancer
Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial
This study is testing whether a shorter, more intense type of radiotherapy after breast-conserving surgery can control tumor recurrence just as well as the traditional, longer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4052 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Guiyang, Guizhou and 4 other locations) |
| Trial ID | NCT04025164 on ClinicalTrials.gov |
What this trial studies
This study investigates whether hypofractionated radiotherapy (HF-RT) is as effective as conventional fractionated radiotherapy (CF-RT) in controlling tumor recurrence in patients who have undergone breast conserving surgery. Eligible participants will be randomly assigned to receive either HF-RT, which involves a shorter treatment duration with higher doses per session, or CF-RT, which involves a longer treatment duration with lower doses per session. The primary focus is on loco-regional recurrence, with additional evaluations of cancer-related events and radiation side effects over a follow-up period of 10 years. The hypothesis is that HF-RT will provide comparable outcomes to CF-RT.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-70 with a single lesion of pathologically confirmed invasive breast cancer who have undergone breast conserving surgery with negative margins.
Not a fit: Patients with distant metastases, multiple lesions, or those who have received neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient radiotherapy regimen that reduces treatment time for breast cancer patients without compromising tumor control.
How similar studies have performed: Previous studies have shown promising results for hypofractionated radiotherapy in various cancer types, suggesting potential success for this approach in breast cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age18-70 years * Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy * Receive breast conserving surgery with negative margins * Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed. * The tumor bed is labeled with clips and it can be drawn on the treatment planning system. * Pathologically confirmed invasive breast cancer * Pathologically stage is T1-3N0-3M0 * Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery * No distant metastases * No supraclavicular or internal mammary nodes metastases * No neoadjuvant chemotherapy * Fit for postoperative radiotherapy. No contraindications to radiotherapy * KPS≥80 * Signed informed consent Exclusion Criteria: * T4 or M1 breast cancer * Supraclavicular or internal mammary nodes metastases * Pathologically confirmed DCIS only without an invasive component * Bilateral breast cancer or historically confirmed contralateral invasive breast cancer * Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy * Multiple lesions can not be removed by single quadrantectomy * Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) * KPS ≤ 70 * Patients with severe non-malignant comorbidity in cardiovascular or respiration system * Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin * Previous radiotherapy to the chest wall or regional lymph node areas * Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis * Pregnant or lactating * Conditions indicating that the patient cannot go through the radiation therapy or follow up * Unable or unwilling to sign informed consent
Where this trial is running
Guiyang, Guizhou and 4 other locations
- Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
- Suzhou Municipal hospital — Suzhou, Jiangsu, China (Recruiting)
- The Second Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
- Shanghai Huangpu District Central Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiaoli Yu, MD, PhD — Fudan University
- Study coordinator: Xiaoli Yu, MD, PhD
- Email: stephanieyxl@hotmail.com
- Phone: +86-13817893133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.