Actively Recruiting
Led by Fudan University · Updated on 2021-10-25
1650
Participants Needed
1
Research Sites
52 weeks
Total Duration
F
Fudan University
Lead Sponsor
T
The First Affiliated Hospital of University of Science and Technology of China
Collaborating Sponsor
Researchers are investigating treatment options for patients with locally advanced breast cancer who have a high risk of cancer returning after surgery. This phase III trial compares two ways of delivering radiation therapy to regional lymph nodes, focusing on whether irradiating the entire supraclavicular lymph node area is better than targeting only the medial supraclavicular lymph node area. The goal is to see which method improves disease free survival and reduces recurrence risk after breast cancer surgery. Participants will be randomly assigned to receive radiation therapy targeting the breast or chest wall, undissected axillary nodes, internal mammary nodes, and either just the medial supraclavicular lymph nodes or the entire supraclavicular lymph node region. Radiation is given either as conventional fractionated therapy (50 Gy in 25 fractions over 5 weeks) or hypofractionated therapy (42.5 Gy in 16 fractions over 3.5 weeks) using advanced radiation techniques such as IMRT or VMAT. The study does not allow 3DCRT technique. During the study, participants will be monitored for disease free survival up to five years after completing radiation therapy. Researchers will also evaluate overall survival, recurrence in the supraclavicular nodes, local regional recurrence, distant metastasis, radiation side effects, quality of life, and upper limb function over this period. Assessments will occur regularly to track these outcomes and safety.
CONDITIONS
Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3.5 to 5 weeks
Participants receive radiation therapy to the breast/chest wall, undissected axillary, internal mammary nodes, and either medial or entire supraclavicular lymph nodes using recommended IMRT or VMAT techniques. Treatment is given using either conventional fractionation or hypofractionation schedules.
Daily visits for radiation therapy 16 to 25 sessions over 3.5 to 5 weeks
Duration - Up to 5 years
Participants are followed for up to 5 years after completion of radiation therapy to monitor disease-free survival, overall survival, recurrence, adverse events, quality of life, and upper limb function.
Regular follow-up visits as scheduled by the study team
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Z
Zhaozhi Yang, M.D.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Li Zhang, Xin Mei, Zhigang Hu...
https://pubmed.ncbi.nlm.nih.gov/38195438