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Anatomy Impact on RT Breast Cancer

Anatomy Impact on RT Breast Cancer

Recruiting
18 years and older
Female
Phase N/A

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Overview

Prospective observational study. The purpose of this project is to identify a parameter system that will allow to identify a priori the most appropriate radiotherapy technique for each patient undergoing breast radiotherapy at our center.

All patients will be treated and monitored according to the local clinical practice. A total of at least 30 patients will be included in the study. Dose prescription will be 40.05 Gy (Gray) in 15 fractions.

For each patient, 3 RT treatment plans will be simulated: Three-Dimensional Conformal Radiation Therapy (3D-CRT), Step-and-shoot intensity-modulated radiotherapy (IMRT S\&S), and hybrid technique (3D-CRT+IMRT). A total of 90 plans will be available. The best treatment technique will be chosen based on scoring provided by at least 3 expert clinicians. The primal plan choice will be the one with higher total rate, evaluated as a sum of 3 single rates.

Description

To date, at IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST) there is no system of objective criteria that allows the planner to determine the optimal planning and treatment technique based on the patient's characteristics.

This is a prospective observational study (non interventional study). Therefore no changes will be performed on clinical practice already in use.

Any decision about drug administration is made by the physician based on his clinical judgment in the context of clinical practice, independently from the decision to include the patient in this study.

Patients participating in the trial will not be subjected to any procedure that falls outside the clinical practice; in the same way, clinical variables that will be collected for the study are those that are commonly collected by physician in daily clinical practice. A total of at least 30 patients will be included in the study. Dose prescription will be 40.05 Gy (Gray) in 15 fractions. For each patient, 3 RT treatment plans will be simulated: 3D-CRT, IMRT (S\&S), and hybrid technique (3D-CRT+IMRT). A total of 90 plans will be available. The best treatment technique will be chosen based on scoring provided by at least 3 expert clinicians. The primal plan choice will be the one with higher total rate, evaluated as a sum of 3 single rates. The study duration will be approximately 30 months.

Eligibility

Inclusion Criteria:

  • Female
  • Target volume: left breast
  • Tumor type: any diagnosis of breast cancer
  • Dose prescription: 40.05 Gray/15 fractions
  • Patients aged ≥ 18 years old
  • Patients willing and able to give informed consent to participate

Exclusion Criteria:

  • Other concomitant tumor lesions
  • Sovraclavear lymph node involvement

Study details
    Breast Cancer

NCT07881341

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

21 October 2026

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