Actively Recruiting
Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction
Led by Barretos Cancer Hospital · Updated on 2022-08-08
120
Participants Needed
1
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
RATIONALE: Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome. There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis. PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.
CONDITIONS
Official Title
Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with confirmed histological diagnosis of invasive ductal carcinoma and lobular breast carcinoma;
- Radical mastectomy with immediate reconstruction with a prosthesis;
- Patients indicated for adjuvant RT;
- Any lymph node status;
- With or without adjuvant chemotherapy;
- ECOG performance status from 0-2;
- > 18 years old;
- Informed Consent Form applied before any study-specific procedure.
You will not qualify if you...
- Another histological diagnosis than invasive ductal carcinoma or lobular carcinoma;
- Previous history of neoplasm and/or radiotherapy and/ or quimiotherapy before this study;
- Distant metastatic disease;
- Palliative treatment;
- Patients with scleroderma / systemic lupus erythematosus.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Radiation Oncology Department
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
Research Team
M
Marcos D Mattos, MD, MS
CONTACT
A
Alexandre A Jacinto, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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