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Trial Title:
Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction
NCT ID:
NCT05491395
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer, radiation therapy, hypofractionated, biomarkers
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Arm Experimental: Post Mastectomy Hypofractionated Radiotherapy Arm No Intervention: Post
Mastectomy Conventional Radiotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionation
Description:
Hypofractionation scheme will comprise 40 Gy in 15 fractions
Arm group label:
Post Mastectomy Hypofractionated Radiotherapy Arm
Summary:
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.
Detailed description:
General aim: To evaluated if hypofractionated accelerated radiotherapy in patients with
breast cancer undergoing immediate breast implant reconstruction surgery is non inferior
to conventional radiotherapy.
Aim 1 (Primary objective): Assess the G3 toxicity rate - loss of the prosthesis
(complication that requires surgical intervention: capsular contracture, leakage,
infection, malpositioning).
Aim 2 (Specific secondary objectives):
- Compare local recurrence rate between two groups;
- Compare quality of life index between two groups using EORTC QLQ-C30 / EORTC
QLQ-BR45 scales during treatment, after 6 and 12 months after treatment ending;
- Compare self-image differences between groups;
- Compare acute and late radiodermatitis rates by CTCAE 4.0;
- Analyse dosimetric planning differences considering the volumes of all breast and
breast without prosthesis;
- Study inflammation molecular markers, which may indicate an increased risk of
fibrosis;
- Evaluate the change in the profile of extracellular vesicles in patients treated
with RT hypofractionated and conventional;
- Evaluate the change in EV collagen production after in vitro irradiation, using
co-culture experiments with breast cells and fibroblasts.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Radiation Oncology Department
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Marcos D Mattos, MD, MS
Phone:
+5517981140230
Email:
marcosbtos3@gmail.com
Contact backup:
Last name:
Alexandre A Jacinto, MD, PhD
Phone:
+551733216600
Phone ext:
7342
Email:
jacintoaa@gmail.com
Start date:
June 27, 2022
Completion date:
May 1, 2029
Lead sponsor:
Agency:
Barretos Cancer Hospital
Agency class:
Other
Source:
Barretos Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05491395
