CHT-NMIBC/ INVESTIGATING THE IMPACT OF HYPERTHERMIC INTRAVESICAL ADMINISTRATION OF EPIRUBICIN IN PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CANCER [PN-III-P1-1.1-PD-2019-0085], director proiect: Vartolomei
| Proposal Registration Code | PN-III-P1-1.1-PD-2019-0085 |
| Project Registration Code | PD 186/2020 |
| Project Acronym | CHT-NMIBC/ Investigating the impact of hyperthermic intravesical administration of Epirubicin in patients with non-muscle invasive bladder cancer |
| Purpose and project planning | In a prospective nonrandomized case-control study we will investigate the impact of chemohyperthermia (CHT) administration of Epirubicin (EPI) in patients with intermediate and high risk non-muscle invasive bladder cancer (NMIBC). We will prospectively include patients with non-muscle invasive bladder cancer that search treatment in our department for the next two years. Patients will be divided 1 by 1 into 2 groups: CHT and no-CHT. Treatment consists of an induction phase comprised of 6 instillations and a maintenance phase comprised of 6 instillations of 50ml EPI at a concentration of 1mg/ml. The CHT instillations consist of circulating the EPI through the bladder at 44.5°C for 50 minutes. We will build a prospective database that will include all demographic (age, gender, smoking, working exposure to chemicals), clinic (stage, number of tumors, diameter, markers of inflammation NLR and CRP) and pathological (stage, grade, lymphovascular invasion, necrosis, concomitant CIS etc.) data related to patients included with regular follow-up according to the 2019 EAU/ESMO guidelines. |
| Project Start Date | 01.09.2020 |
| Project End Date | 31.08.2022 |
| Project Duration | 24 months |
| Main objectives | Aim 1- to investigate the impact of chemohyperthermia (CHT) administration of Epirubicin (EPI) on oncological outcomes of non-muscle invasive bladder cancer (NMIBC) (12 and 24 months recurrence and progression free survival) compared to standard EPI intravesical instillations; Aim 2 – to investigate the toxicity of CHT with EPI and to compare it with the toxicity of standard EPI administration; Aim 3 – to prospectively validate blood based biomarkers such as neutrophil-to-lymphocytes ratio (NLR) and C reactive protein (CRP); Aim 4 – to build a prospective database |
| Team: | Name -> Role Vartolomei Mihai Dorin -> Leader Sin Anca Ileana -> Mentor |
| Results | Study outcomes will refer to time-points as: primary – time to recurrence and progression at 12 and 24 months; secondary – tolerability and quality of life (QoL). |
| Host institution | George Emil Palade University of Medicine, Pharmacy, Sciences and Technology from Tirgu Mures |