Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
NCT Number: NCT06464913
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Neoplasms
Interventions: RADIATION: With or without chest wall RT
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2029-09
Locations: The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310000, China

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.

Primary Outcome Measures: Reconstruction failure rate (Capsular Contracture Grade III or higher), Physicians assess the hardness, shape of the breast, and the presence of any abnormal hard lumps or asymmetry through palpation. According to the Baker classification system, capsular contracture is divided into four grades; Grades I and II typically have no clinical significance, while Grades III and IV require further evaluation and possible treatment.

Breast Ultrasound or Chest CT is used to assess the condition of the implant and surrounding tissues. Particularly, the thickening of the fibrous capsule is considered an objective sign of capsular contracture.

In cases where the results of the ultrasound examination are unclear or a more detailed assessment is needed, MRI may be required to evaluate the implant and surrounding tissues., 2 years postoperatively|The 3-year local recurrence rate (LRR), The 3-year LRR refers to the proportion of patients who experience a cancer recurrence within the breast tissue or chest wall area, or in the regional lymph nodes, within three years following the initial treatment.

To determine the local recurrence rate, medical professionals:

Conduct regular follow-up examinations, including physical assessments and patient-reported symptoms.

Utilize imaging techniques such as mammography, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) when indicated.

May also consider the use of tumor markers in blood tests to monitor for signs of recurrence., 3 years postoperatively
Secondary Outcome Measures: Breast-Q score, The Breast-Q score is a patient-reported outcome measure (PROM) specifically designed to assess the satisfaction and quality of life of patients who have undergone breast surgery.The questionnaire assesses multiple dimensions, including body image, pain, sexual life, and satisfaction, to comprehensively reflect the quality of life and the success of postoperative surgery for patients. Patients self-assess based on the questions in the scale, with each question usually having multiple levels to choose from, and different scores are assigned according to the level selected. The total score is obtained by summing the scores of all questions. The higher the Breast-Q score, the better the patient's quality of life and the greater the satisfaction with the surgery., 2 years postoperatively|PROs and QoL score, Satisfaction score (patient-reported outcome) and Quality of Life (QoL) score Measurement Method: A questionnaire is designed based on the assessment dimensions of the patient's physical function, mental health, social function, pain, satisfaction, body image, sexual function, etc., including multiple-choice questions, single-choice questions, scale scoring (such as VAS), open-ended questions, etc., 3 years postoperatively|3-year disease free survival rate (DFS), The 3-year DFS rate refers to a percentage of patients who are disease-free at the three-year mark after their initial treatment. Researcher conduct regular follow-up assessments, including physical examinations and patient-reported outcomes. Utilize imaging studies such as mammograms, CT scans, MRI, or PET scans when appropriate. Monitor for any signs or symptoms that may indicate a recurrence of the disease., 3 years postoperatively