Viewing Study NCT03339531



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Study NCT ID: NCT03339531
Status: COMPLETED
Last Update Posted: 2018-03-13
First Post: 2017-11-03

Brief Title: Optimized 2D-RT for Prostate Cancer
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Overview

Official Title: Definition of Fields Margins for Optimized 2D Radiotherapy of Prostate Carcinoma
Status: COMPLETED
Status Verified Date: 2018-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Prostate cancer CAP is one of the most common malignancies in men both in Western countries and developing countries Radiation therapy RT is an important therapeutic option New technologies 3D IMRT IGRT VMAT have been introduced in the last decades with a progressive improvement of clinical outcome However in many countries the only treatment option is the traditional 2D technique based on standard simulation The indications for field definition in this treatment are still based on experts opinions The aim of this analysis is to propose new indications for 2D fields definition based on three-dimensional simulation in a population of patients with CAP Twenty patients with CAP consecutively treated with RT in our center were identified Patients underwent CT-simulation in supine position Pelvic MRI images were fused with CT-simulation images In this way delineation of the prostate and seminal vesicles was performed on MRI images Clinical Target Volume definition CTV was performed according to EORTC guidelines simulating 4 different categories low-risk CAP intermediate-risk CAP high-risk CAP without involvement of the seminal vesicles and high-risk CAP with involvement of seminal vesicles The Planning Target Volume PTV was defined by adding a margin of 10 mm to the CTV in all directions For each patient 8 treatment plans were calculated In particular for each of the 4 categories of risk 2 treatment plans were calculated by using a cobalt source or 10 MV photons Treatment plans were calculated using the box technique Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution Once the final plan was achieved respecting the PTV constraint D98 95 distances of the fields edges from a set of reference points were measured
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None