CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 480 enrolled
Drug / intervention
Adjuvant Radiotherapy +1 moreradiation
Likely dose
Not stated in record
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Search/NCT06780059
NCT06780059N/ACompleted

Effects of Radiotherapy on Recurrence and Survival in Borderline and Malignant Phyllodes Tumors After R0 Resection: a Propensity Score Analysis

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University·observational·Posted Jan 17, 2025·Updated Jan 17, 2025

In Brief

An observational study evaluating Adjuvant Radiotherapy and R0 resection for Radiotherapy, Adjuvant and 2 related conditions. Completed, enrolled 480 participants across 3 sites.

Detailed Summary

Breast phyllodes tumors (PT) are rare fibroepithelial neoplasms originating from stromal tissue and account for less than 1% of all breast tumors. The World Health Organization (WHO) classifies PT into benign, borderline, and malignant subtypes based on pathological features such as mitotic activity, cellular atypia, tumor margin invasion, and stromal composition 1. The presence of malignant heterologous elements characterizes the tumor as malignant 2. Surgery is the primary treatment. However, even after R0 resection, borderline phyllodes tumors (BoPT) and malignant phyllodes tumors (MPT) patients remain face a high risk of local recurrence, with rates of 15%-20% and 25%-30%, respectively. Moreover, metastases occur almost merely in MPT, with a distant metastasis rate reaching 22%. Adjuvant radiotherapy has attracted attention for its potential to improve local control and reduce recurrence, but the role after R0 resection in PT patients remains unclear. Radiotherapy significantly reduces local recurrence rates in BoPT and MPT but shows no substantial benefit in benign cases. However, a meta-analysis by Yu et al. found that this effect is limited to MPT. Additionally, the effect of radiotherapy on survival rates in PT remains controversial. Most existing studies are retrospective and face limitations such as small sample sizes. The rarity of PT and conflicting evidence of impact of radiotherapy necessitate further study. While prospective trials are difficult due to limited cases, well-designed retrospective studies can offer valuable insights. In this study, the investigators also analyzed prognostic factors and identified subgroups to provide a clinical reference for the application of postoperative radiotherapy in BoPT and MPT patients.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedJan 17, 2025
Enrollment StartDec 30, 2024
Primary CompletionJan 2, 2025
TodayJul 2, 2026
Enrollment to primary: 2 daysPosted 1.5 years ago

Interventions

Adjuvant Radiotherapyradiation

Postoperative Radiotherapy with 3D-CRT and IMRT Techniques Following R0 Resection in BoPT and MPT Patients

R0 resectionprocedure

Patients who received R0 resection (complete resection without tumor margin)