Health TrialsbyHealthPanel

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBarretos Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypofractionation

    Radiation

    Hypofractionation scheme will comprise 40 Gy in 15 fractions

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Post Mastectomy Hypofractionated Radiotherapy ArmExperimental treatment 1 intervention
Group B: Post Mastectomy Conventional RadiotherapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Assess the G3 toxicity rate

loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning)

Time frame
2 years

Secondary outcomes

1

Local recurrence

Compare local recurrence rate between two groups

Time frame
5 years
2

Assessment of quality of life through the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire

Compare quality of life index between two groups using EORTC scales during treatment, after 6 and 12 months after treatment ending

Time frame
2 years
3

Comparison of self-image using the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire

Compare self-image differences between groups

Time frame
5 years
4

Compare acute and late radiodermatitis rates by Common Terminology Criteria for Adverse Events (CTCAE) 4.0

Acute and late radiodermatitis rateswill be evaluated by CTCAE 4.0 scale, using the adverse event (AE) reporting. A grading (severity) scale is provided for each AE term.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barretos Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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