NCT04025164 Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
| NCT ID | NCT04025164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,052 participants |
| Start Date | 2018-07-01 |
| Primary Completion | 2023-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,052 participants in total. It began in 2018-07-01 with a primary completion date of 2023-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery
Eligibility 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
Contact & Investigator
Xiaoli Yu, MD, PhD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT04025164 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04025164 currently recruiting?
Yes, NCT04025164 is actively recruiting participants. Contact the research team at stephanieyxl@hotmail.com for enrollment information.
Where is the NCT04025164 trial being conducted?
This trial is being conducted at Guiyang, China, Suzhou, China, Dalian, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT04025164 clinical trial?
NCT04025164 is sponsored by Fudan University. The principal investigator is Xiaoli Yu, MD, PhD at Fudan University. The trial plans to enroll 4,052 participants.
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