Particle Therapy 2017

Clinical Trials : Carbon Ions

https://clinicaltrials.gov.it

Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate

Cancer

(Shanghai Proton and Heavy Ion Center) NCT02935023 Phase II

àSingle Group Assignment

àT1-4,N0-1,M1a/b, maximum of 3 synchronous lesions, NO visceral mets.

à59.2GyE/16Fx to

prostate

and seminal vesicle + HT or CHT

àPrimary Outcome: Time to PSA relapse

àSecondary Outcome: PFS, OS, QoL

Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

(Shanghai Proton and Heavy Ion Center) NCT02739659 Phase I-II

àSingle Group Assignment

Pathologically confirmed adenocarcinoma of the prostate, N0 M0

Phase I : Four dose levels 59.2 GyE(Gray equivalent)/16Fx, 60.8 GyE/16Fx, 62.4 GyE/16Fx, 64.0

GyE/16Fx.

àPrimary Outcome: to determine the maximal tolerated dose (MTD) of CIRT in the treatment of localized prostate

cancer.

Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer

(European Institute of Oncology-CNAO) NCT02672449 Phase II

Single Group Assignment

àT3a and/or PSA > 20 ng/ml and/or GS 8-10, cN0, cM0.

à45 Gy (1.8Gy/day) to pelvic lymph nodes, prostate and seminal vesicle (IMRT) + boost with carbon ion 16.6 GyE

in 4 fractions (4.15 GyE/fraction).

àPrimary Outcome: Grade 3 or Grade 4 adverse events that are related to radiotherapy (RTOG/EORTC)