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Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction

NCT06464913 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2024-10-15

No results posted yet for this study

Summary

The goal of this randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients. The main questions it aims to answer are:

* Can omitting chest wall RT after prosthetic reconstruction reduce the failure rate of breast reconstruction without significantly increasing the local recurrence rate?
* Does this approach ensure an improvement in the quality of life for patients without sacrificing therapeutic effectiveness?

Participants will:

* Be randomly assigned to one of two groups.
* One group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas.
* The other group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas.
* Participate in follow-up assessments to monitor reconstruction failure rates and local recurrence rates.

If there is a comparison group: Researchers will compare the outcomes of the two groups to evaluate the impact of chest wall RT omission on reconstruction failure and local recurrence risks.

Conditions

  • Breast Neoplasms

Interventions

RADIATION

With or without chest wall RT

Supraclavicular and infraclavicular lymphatic drainage area radiotherapy with or without chest wall RT

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2028-09-01
Completion
2029-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06464913 on ClinicalTrials.gov