An observational study in Breast Cancer, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Observational
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 30 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS is the lead sponsor of 60 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients treated for breast cancer (on the left breast) at Radiotherapy Facility of IRCCS IRST in Meldola (FC, Italy).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Consecutive patients treated for breast cancer (on the left breast) at Radiotherapy Facility of IRCCS IRST in Meldola (FC, Italy)
Identification of a parameter system for most appropriate radiotherapy technique choice
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.
Time frame: 24 months
Evaluation of the clinician concordance
Assess the concordance within clinician scoring of best treatment choice for each case
Time frame: 24 months
Started Jun 2023 (actual). Primary completion is estimated for Nov 2026, 41 months after the start.
Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's planned 41 months is below that.
Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS