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NCT06780059Completed

Effects of Radiotherapy in Borderline and Malignant Phyllodes Tumors After R0 Resection

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

Source: ClinicalTrials.gov · Last updated 17 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
480 (actual)
First submitted
10 Jan 2025
Start date
30 Dec 2024
Primary completion date
2 Jan 2025
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT number
NCT06780059

What you commit to

  • Study type: Observational
  • Participants enrolled: 480
  • From 30 Dec 2024 to the primary completion date, 2 Jan 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • patients who had their initial surgery at other hospitals without accurate baseline data
  • patients who received radiotherapy before surgery
  • patients with a history of or concurrent breast cancer or precancerous lesions in the ipsilateral breast or with breast cancer in the contralateral breast

Other

  • those presenting with initial distant metastasis before treatment
  • patients lost to follow-up after treatment

Who the study is looking for

  • patients who were initially diagnosed with BoPT or MPT and underwent R0 resection surgery

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Third Hospital of Nanchang
Coordinator of this site? Confirm its status
NanchangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.