NCT05976412RecruitingNot Applicable
Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 1,355
- Locations
- 1
- Primary Endpoint
- 5 year disease free survival rate
Study Overview
Brief Summary
This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntarily participate and sign an informed consent form; Age>18 years old, female； received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection； Invasive cancer, postoperative axillary lymph node negative, with pathological staging of T1-3N0M0 stage (Stage IA, IIA, IIB)； including two or more high-risk factors based on four clinical high-risk recurrence factors [tumor size (>2cm), tumor site (medial and central quadrants), Ki-67 level (>14%), and vascular status (positive)]; KPS ≥ 80, estimated survival time >5 years; Complete healing of Surgical incision, no incision infection, etc; Reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study
Exclusion Criteria
- •Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; History of malignant tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ); Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by pathology or imaging;
Outcomes
Primary Outcomes
5 year disease free survival rate
Time Frame: 5 year
Disease free survival rate from randomization to 5 years after radiotherapy
Secondary Outcomes
- 5 year local reginal recurrence rate(5 year)
- 5 year distant metastases rate(5 year)
- 5 year overall survival rate(5 year)
Investigators
JIAYI CHEN
Prof
Ruijin Hospital
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or NotArthroplasty, Replacement, HipBlood TransfusionBlood Transfusion, AutologousNCT00822588Wellspect HealthCare227
Not yet recruiting
Not Applicable
A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant DeviceOpen Fractures, Degenerative Osteoarthritis and Degenerative Spinal DiseasesNCT04481269Second Affiliated Hospital, School of Medicine, Zhejiang University240
Completed
Not Applicable
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study AArthroplasties, Replacement, KneeNCT02516163Stryker South Pacific55
Unknown
Not Applicable
0.2% Chx Gel vs Implant Bacterial ContaminationBone ResorptionBacteria Caused DiseaseNCT03431766G. d'Annunzio University36
Completed
Not Applicable
High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative PatientsInfection ViralUveitis, PosteriorNCT03598452Aier School of Ophthalmology, Central South University33