Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT02672449 |
Other study ID # |
IEO 98 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2015 |
Est. completion date |
December 2023 |
Study information
Verified date |
June 2023 |
Source |
European Institute of Oncology |
Contact |
Roberto Orecchia, MD |
Email |
roberto.orecchia[@]ieo.it |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of this research project is to test the feasibility and safety of a new treatment
schedule for high risk prostate cancer that allows the administration of high doses to the
prostate tumor with a mixed beam approach of carbon ions boost followed by pelvic IMRT.
Description:
The present research project aims to improve the current treatment for high risk prostate
cancer, evaluating the safety and feasibility of a new RT scheme of a carbon ions boost
followed by pelvic photon RT.
A total of 65 consecutive patients will be enrolled in a prospective phase II trial. The
patients will be enrolled either at Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia,
Italy, at the Division of Radiation Oncology of the European Institute of Oncology (IEO),
Milan, Italy, or at the Fondazione IRCCS Istituto Nazionale Tumori (INT), Milan, Italy.
The treatment will include a boost phase on the whole prostate with carbon ions performed at
CNAO followed by a pelvic photon IMRT performed with conventional fractionation of 1.8 Gy per
fraction up to 45 Gy to the pelvic lymph nodes, prostate and seminal vesicles. All the
patient data will be collected in a common database accessible from the 3 Institutions.
At CNAO, carbon ions beam is available for patient treatment since 2011. In comparison to the
Japanese Center NIRS, the facility relies on active beam delivery using the rasterscan
technique, which offers not only physical advantages with better sparing of normal tissues in
the entrance channel, but also enables biologic plan optimization. The facility has the same
equipment as the Carbon Ion Treatment Center in Heidelberg, Germany. At CNAO, 3D - 4D patient
target localization is verified at each fraction by integrating orthogonal X-ray images and
3D real time optical tracking system.
At IEO and INT, the IMRT phase will be performed with the same treatment modality:
volumetric-IMRT RapidArc by Varian Trilogy (IEO) and Varian DHX (INT) linacs, Varian Medical
Systems, Palo Alto, CA, USA, with treatment based on the isocentric beam delivery, and
pre-treatment image guidance for patient alignment via cone beam CT or portal imaging.
In phantom, quality assurance (QA) of each treatment will be performed before patient RT, in
order to verify the consistency between calculated and delivered dose.