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INSTITUTE OF ONCOTHERAPY

  

INTRODUCTION

 

The Institute of Oncology provides radiation therapy treatment for oncology patients of Baranya and Tolna counties. It serves as an oncology centre for the South Transdanubia region of Hungary.

A staff of 100 people administer 150 radiation and 60-80 infusion treatments for outpatients every day. The institute 
provides consultation or control examinations for 500 outpatients, and it has 55 beds for inpatiens.

Alongside to the usual multidisciplinary oncoteam meeting an oncotherapy team meeting jointly determine the most 
effective therapy for each of our patients for each new treatment. This type of quality assurance system is unique. 
Effective oncological drug treatments are available at our Institute or at the Clinical Centre.

We are regularly involved in multicentric clinical trials for various indications and tumour cases, thus we provide many
patients with the most up-to-date drug therapy.

We are able to treat our patients with unique methods, such as stereotactic radiosurgery which uses a NOVALIS TX 
irradiation unit. This was installed in 2011, and enables us to provide state-of-the-art radiotherapy at national level for 
patients with neurological, laryngeal, gastric, gynaecological, prostate or paediatric oncology cancers.

The institute renewed the rest of the radiation therapy machines in 2015 as part of the TIOP 2.2.6 project. Thus we use 
devices for treatment with the latest technolgy.

The building was renovated, and a southern wing with new laboratory units (infusion mixture preparing CATO 
laboratory) was created. All this refubishment was supported by a European Union grant.

After a year and a half of refurbishment, from 23 May 2016, patients are able to use the new building and the renewed 
environment. Collaboration with several theoretical, state-of-the-art diagnostic and clinical units will support our work, 
thus ensuring oncology patient care at university-level.


Number of clinical trial investigators with a Good Clinical Practice (GCP) certificate :
Number of clinical trial doctors with Good Clinical Practice (GCP) certificate: 11 
Number of specialist doctors with Clinical Pharmacology certificate: 0

 

EQUIPMENT FOR CLINICAL TRIALS

  • centrifuge with refrigerator
  • 2 chilled blood storage containers (-8°C, -20°C, -70°C)
  • 2 ECG devices with leads
  • blood pressure meter
  • height and weight scales
  • thermometers for monitoring refrigerators
  • alarm systems for refrigerators
  • uninterruptible power supply for the building
  • archiving room


 

 

 

REFERENCE CLINICAL TRIALS

  

 

 

Protocol Identifier

Name of Study

Principal Investigators

1

BO21990

A randomized, double-blind, placebo - controlled, multicentre Phase III clinical trial comparing bevacizumab + temozolomide + radiotherapy followed by bevacizumab + temozolomide treatment versus placebo + temozolomide + radiotherapy followed by placebo + temozolomide treatment in newly diagnosed glioblastoma patients

Prof. Dr. László Mangel

2

TS-P04832,

TS-P04833,

TS-P04834

A Phase III, multicentre, randomised, double-blind, active-controlled, multicentre, randomised, double-blind study of the safety and efficacy of rolapitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). in the prevention of nausea and vomiting (CINV) induced by 

Prof. Dr. László Mangel

3

NBTXR3

A Phase II and III, multicentre, randomised, open-label clinical trial comparing the efficacy of  radiotherapy - activated intratumoral NBTXR3 versus radiotherapy alone in patients with limb and trunk wall soft tissue sarcoma

Prof. Dr. László Mangel

 

 

OUR PUBLICATIONS

 

Bonvalot S., Rutkowski PL., Thariat J., Carrère S., Ducassou A., Sunyach MP., Agoston P., Hong A., Mervoyer A., Rastrelli M., Moreno V., Li RK., Tiangco B., Herraez AC., Gronchi A., Mangel L., Sy-Ortin T., Hohenberger P., de Baère T., Le Cesne A., Helfre S., Saada-Bouzid E., Borkowska A., Anghel R., Co A., Gebhart M., Kantor G., Montero A., Loong HH., Vergés R., Lapeire L., Dema S., Kacso G., Austen L., Moureau-Zabotto L., Servois V., Wardelmann E., Terrier P., Lazar AJ., Bovée JVMG., Le Péchoux C., Papai Z.: NBTXR3, a first-in-class radioenhancer hafnium oxidenanoparticle, plus radiotherapy versus radiotherapy alone inpatients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial. Lancet Oncol. 2019 Jul 8. pii: S1470-2045(19)30326-2.

 

Gorbunova VBeck JTHofheinz RDGarcia-Alfonso PNechaeva MCubilloGracian AMangel LElezFernandez EDeming DA, Ramanathan RKTorres AHSullivan DLuo YBerlin JD.: A phase 2 randomised study of veliparib plus FOLFIRI±bevacizumab versus placebo plus FOLFIRI±bevacizumab in metastatic colorectal cancer.Br J Cancer 2019;120(2):183-189.

 

Baselga J., Zamagni C., Gómez P., Bermejo B., Nagai SE., Melichar B., Chan A., Mangel L, Bergh J., Costa F., Gómez HL., Gradishar WJ., Hudis CA., Rapoport BL., Roché H., Maeda P., Huang L., Meinhardt G., Zhang J., Schwartzberg LS.. RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer. Clin Breast Cancer. 2017 (8):585-594.e4.

 

 

 

PRINCIPAL INVETIGATORS

 

 

Prof. Dr. László Mangel 

SCIENTIFIC DEGREEPhD, Med. habile
POSITIONUniversity Professor
QUALIFICATIONSPsychiatry, Radiation therapy, Clinical oncology
SCIENTIFIC INTERESTmodern radiotherapy, neuro-oncology, treatment of tumours in urinary 
tract and mammal
REFERENCE CLINICAL TRIALS

BO21990: A randomized, double-blind, placebocontrolled, multicentre Phase III clinical trial comparing bevacizumab + temozolomide + radiotherapy followed by bevacizumab + temozolomide treatment versus placebo + temozolomide + radiotherapy followed by placebo + temozolomide treatment in newly diagnosed glioblastoma patients. Number of patients: 12
 

TS-P04832, TS-P04833,TS-P04834: A Phase III, multicentre, randomised, double-blind, active-controlled, multicentre, randomised, double-blind study of the safety and efficacy of rolapitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).
Number of patients: 1, 29, 49


NBTXR3: A Phase II and III, multicentre, randomised, open-label clinical trial comparing the efficacy of radiotherapy-activated intratumoral NBTXR3 versus
radiotherapy alone in patients with limb and trunk wall soft tissue sarcoma.
Number of patients: 5, 4 against exclusive radiotherapy, do you suffer from soft tissue sarcoma of the limb and trunk wall? for patients, number of patients included: 5,4
 

AVAILABLE FOR PERFORMING CLINICAL TRIALSPhase 2-4

 

 Dr. Szabolcs Bellyei 

SCIENTIFIC DEGREEPhD, Med. habile
POSITIONUniversity Associate Professor
QUALIFICATIONSRadiation therapy, Clinical oncology
SCIENTIFIC INTERESToncological treatment of head and neck and colorectal tumors 
REFERENCE CLINICAL TRIALS

WO40242: Phase III, Multicentre, randomised, double-blind, placebo-controlled trial studying the use of atezolizumab (ANTI PD-L1 Antibody) in
adjuvant therapy following definitive local therapy in patients with high-risk locally advanced head and neck squamous cell carcinoma. Number of patients: enrolment ongoing

AVAILABLE FOR PERFORMING CLINICAL TRIALSPhase 2-4

 

  

  

STUDY TEAM

 

Study Coordinators

Our clinic has its own study coordinator.


Number of study coordinators with master degree (MSc): 1
Number of study coordinators with bachelor degree (BSc): 0
Number of study coordinators with further education degree: 0

 

Name

Phone

E-mail

Szatyor-Járkovich Andrea

+36 20 254 6528

andrea.jarkovich@coordination.hu

 

 

Study Nurses

Our institute has 5 study nurses. 


Number of study coordinators with master degree (MSc): 0
Number of study coordinators with bachelor degree (BSc): 2 
Number of study coordinators with further education degree: 3

 

Name

Phone

E-mail

Zoltán Kőszegi

+36 72 536 000 / 32875 ext

koszegi.zoltan@pte.hu

Boglárka Krém

+36 72 536 000 / 32875 ext

krembogi77@gmail.com

Jánosné Kis

+36 72 536-000 / 32865 ext

kisjanosne57@gmail.com

Katalin Kis

+36 72 536 000 / 32875 ext

kis.katalin1@t-online.hu

Ferencné Takács

+36 72 536 000 / 32875 ext

tbozsi61@freemail.hu

 

A Site Management Organization (SMO) works in our institute.

 


Created: 23.08.2019
Last updated: 09.04.2019.