OI Ljubljana

Clinical Trials

Clinical trials are carried out predominantly within the framework of international studies and associations or European projects. The Institute of Oncology additionally stimulates the clinical studies resulting from our own know-how and initiating as well as evaluating new treatment approaches to cancer.

Clinical studies with ongoing enrolment

Name of studieCarrier
P3-0003 Development and evaluation of new approaches to cancer treatmentMarko Snoj
Nutrition day in European hospitalsNada Rotovnik Kozjek
International clinical study CONVERT - a phase III randomised controlled trial of concurrent once-daily versus twice-daily radiotherapy and chemotherapy for limited stage small cell lung cancerMatjaž Zwitter
Cisplatin with either alimta or gemcitabine in long infusion for mesothelioma: a randomised phase II trial (Agili trial)Viljem Kovac
Treatment of liver metastases with electrochemotherapyEldar Gadzijev
Identification of Men with a Genetic predisposition to ProstAte Cancer: Targeted screening in BRCA1/2 mutation carriers and controls (The IMPACT study)Janez Zgajnar
Prediction of the aesthetic result in breast cancer conservative treatmentJanez Zgajnar
Gemcitabine vs. Gemcitabine-Vincristine for patients with advanced non-small cell lung cancer in performance status WHO 2: A Phase II randomised clinical trial (trial STOG 10)Matjaž Zwitter
European study on MRI-guided brachytherapy in locally advanced cervical cancer-EMBRACEBarbara Segedin
Radiotherapy plus adjuvant temozolomide in the treatment of lung cancer patients with brain metastasesUros Smrdel
Late effects of adjuvant radiochemotherapy in patients with gastric adenocarcinomaIrena Oblak
Evaluation of myocardial damage in breast cancer patients treaded with chemotherapy and trastuzumabErika Matos
A survey of bevacizumab treatment (eVA) for metastatic breast and kidney cancer; the “eVA” survey extended to colorectal cancerJanja Ocvirk
Cancer genetic counselling: knowledge, expectations and attitude among women with familial breast and ovarian cancerMateja Krajc
ITAC trial: Intermittent Tki And Chemotherapy for patients with advanced non-small cell lung cancer

Matjaž Zwitter

A Double Blind Placebo Controlled Randomized Phase II Study Evaluating the Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream in First Lile mCRC Patients Treated with Erbitux and FOLFIRI. E-VITA StudyJanja Ocvirk
A retrospective study of the impact of radiotherapy of the neck region and chemotherapy on tumor progression in patients with differentiated thyroid carcinoma stage T3 and T4 Nikola Besic
Immunocytochemistry and immunohistochemistry staining of follicular thyroid neoplasms with arginase II (ARG2)Nikola Besic
Testing of HER2 Positivity In Adenocarcinoma of stomach or gastroesophageal junction "THEIA"Barbara Gazic
Follow-up of patients with non-small cell lung cancer (stage IIIb/IV) treated with erlotinibMatjaž Zwitter
Treatment selection according to skin reaction to CetuximabBranko Zakotnik/Primož Strojan
Tolerability of additional irradiation of pathologic pelvic nodes shown by PET CT in prostate carcinoma (phase 1-2 study)Borut Kragelj
Induction Chemotherapy,Radiochemotherapy, Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer – OIGIT5-01 phase II studyVaneja Velenik
Palliative care in lung cancer patientsBranko Zakotnik
A randomized study comparing maintainance therapy with subcutaneous rituximab continued untill progression with observation only in patients with relapsed or refractory, indolent non Hodgkin`s lymphoma who completed and responded to rituximab-based immunochemotherapy induction and initial 2-year rituximab maintainance therapy administered subcutaneouslyBarbara Jezersek Novakovic
LUX-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatmentCvetka Grasic Kuhar
APHINITY - A Randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer ("Protocol")Simona Borstnar
A randomized multicenter study of accelerated fractionated radiotherapy with or without the hypoxic radiosensitizer nimorazole in the treatment of squamous cell carcinoma of the head and neckPrimož Strojan
Genetic markers of thyroid Huerthle cell carcinomaNikola Besic
Double blind randomized phase III study of mainteinance Pazopanib versus placebo in NSCLC patients non progressive after first line chemotherapy »MAPPING trial« Mirjana Rajer
Randomized, double-blind, multicenter two-stage adapive phase 3 study of intravenus administration of REOLYSIN® (Reovirus Type 3 Dearing) in combination with palitaxel and carboplatin versus the chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck who have progressed on or after prior platinum-based chemotheralyCvetka Grasic Kuhar
Safety and efficacy of intramuscolar electrotransfer of plasmid AMEP in patients suffering from advanced or metastatic melanoma: An open-label phase I/II clinical trial. The AIMM study (AMEP in metastatic melanoma)Marko Snoj, Gregor Sersa
Genetic counseling, BRCA1/2 status and clinicopathological characteristics in patients with epithelial ovarian cancer younger than 45.Marko Hocevar
Multicentrična odprta raziskava (z eno skupino) pertuzumaba v kombinaciji s trastuzumabom in taksanom za prvo linijo zdravljenja bolnic s HER2-pozitivnim napredovalim (metastatskim ali ob lokalni ponovitvi) rakom dojke, številka protokola: MO28047-PERUSEErika Matos
A single-arm, open-label, phase II, multicenter study to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinomaJanja Ocvirk
Randomized multicentre phase III study od short course radiation therapy followed by prolonged preoperative chemotherapy and surgery in patients with high risk primary rectal cancer compared to standard preoperative chemoradiotherapy, surgery and optional adjuvant chemotherapyIbrahim Edhemovic
A randomized, double-blind, multicenter phase 3 study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progressive during or following first-line combination therapy with bevacizumab, oxaliplatin and fluoropyrimidineJanja Ocvirk
Anamorelin HCl in the Threatment of Non-Small Lung cancer - Cachexia (NSCLC-C): A double-blind extension study - ROMANA 3Mirjana Rajer
Anamorelin HCl in the Threatment of Non-Small Lung cancer - Cachexia (NSCLC-C) - ROMANA 1Mirjana Rajer
Identification of risk for malnutrition and cachexia in SloveniaNada Rotovnik Kozjek
Influence of body composition, nutritional status and cachexia on bioelectrical impedance phase angle in patients with head and neck cancerPrimož Strojan
Local Assessment of Ventilatory Management during General Anesthesia for Surgery and effects on Postoperative Pulmonary Complications: a Prospective Observation International Multi-center Cohort StudyBarbka Novak Supe
Collection of KRAS results and treatment patterns in daily clinical pratice in Slovenia in 1st line treatment of mCRC patients with KRAS wild-type tumorJanja Ocvirk
Cross-tumoral phase 2 clinical trial exploring crizotinib (PF-02341066) in patients with advanced tumor induced by causal alterations of alk and/or MET ("CREATE")Branko Zakotnik
A multicenter, single arm study of trastuzumab-emtansine (T-DM1) in HER2 positive locally advanced or metastatic breast cancer patients who have received prior anti-HER2 and chemotherapy-based treatmentSimona Borstnar
Vitamin K1 impact on the ability to restore skin EGF receptor activity in metastatic colorectal patients treated with EGFR inhibitorJanja Ocvirk
Significance of COX 2 inhibition in first line treatment of extensive disease small-cell lung cancer (ED-SCLC) »COX-2l trial«Mirjana Rajer
A randomized phase II study evaluating different schedules of nab-Paclitaxel in metastatic breast cancer »SNAP Trial«Simona Borstnar
A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing RegimenJanja Ocvirk
Prospective Validation of Genomic Signatures to Predict Treatment Response in the Axillary Nodes after Neoadjuvant Chemotherapy in Patients with HER2-negative Breast CancerJanez Zgajnar
Determination of frequency and predictive value of mutations in VHL, KRAS, BRAF, PIK3CA and PTEN in patients with renal cell carcinoma treated with mTOR inhibitorsSrdjan Novakovic
BRAF Mutation Screening in Metastatic Melanoma »BRAS«Janja Ocvirk
A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate CancerBreda Skrbinc
Spinal Corde Compression Responce Evaluation (Radiotherapy of motor deficits from metastatic epidural spinal cord compression)-SCORE-2Barbara Segedin
Randomizirana študija faze III o zdravilu Ganetespib v kombinaciji z zdravilom Docetaxel v primerjavi z učinkovitostjo zdravljenja samo z Docetaxelom pri bolnikih z napredovanim nedrobnoceličnim pljučnim adenokarcinomomMojca Unk 
EORTC randomizirana raziskava faze II/III predoperativne kemoterapije v primerjavi s predoperativno kemoterapijo pri resektabilnem raku želodca (TOP GEAR)Irena Oblak


Clinical studies with finished enrolment

Naslov študijeNosilec
EORTC 20981 Chimeric anti-CD 20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin`s lymphoma: a phase III randomised clinical trialRadka Tomsic Demsar
An intergroup phase III trial to evaluate the activity of Docetaxel, given einther sequentially or in combination with Doxorubicinion, followed by CMF, in comparison to Doxorubicin alone or in comination with Cyclophosphamide, followed by CMF, in the adjuvant treatment of node-positive breast cancer patients (B.I.G. 2 – 2098) Simona Borstnar
A phase III Study to evaluate letrozol as adjuvant therapy for postmenopausal women with receptor (ER and/or PR) positive tumors (BIG trial 1) IBCSG 18-98 (BIG 1-98)Simona Borstnar
After Mapping of the Axilla: Radiotherapy or Surgery? (AMAROS EORTC 10981)Marko Snoj
A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus  T) as adjuvantdoxorubicin and cyclophosphamide followed by docetaxel (AC treatment of operable breast cancer her2neu negative patients with positive axillary lymph nodes (BCIRG 005 (TAX GMA 301) Erika Matos
First prospective intergroup translational research trial assessing the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane versus a non taxane regimen (EORTC 10994-BIG 00-01)Erika Matos
Multicenter phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC→ T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC→ TH) and with docetaxel, platinum salt and trastuzumab (TCH) in the treatment of node-positive and high risk node-negative adjuvant patients with operable breast cancer containing the HER 2NEU alteration (BCIRG 006 (TAX GMA 302)Erika Matos
PEG-Intron versus Observation after Regional Lymph Node Dissection in AJCC Stage III (TxN1- 2M0) Melanoma Petients: a Randomized Phase III Trial (EORTC Melanoma Coop.Group Trial 18991/PO 00435 (Final ver. 8.2.2000) Janja Ocvirk
IBCSG 25-02: A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer (TEXT)Erik Skof
Cetuximab (Erbitux), Capecitabine and radiotherapy in neoadjuvant
treatment of patients with locally advanced resectable rectal cancer: a Phase II Pilot Study (XERT)
Vaneja Velenik
Multicentre international study of capecitabine + bevacizumab as adjuvant treatment of colorectal cancer (QUASAR2 MO17092)Janja Ocvirk
AVEX Avastin in Elderly with Xeloda A randomized, open-label Phase III study to assess efficacy and safety of bevacizumab in combination with capecitabine as firstline treatment for elderly patients with metastatic colorectal cancer (PROTOCOL MO19286) (AVEX) / EUDRACT # 2006-003293-10) Janja Ocvirk
A randomized, multi-centre, open label, phase III study of adjuvant lapatinib, transtuzumab, their sequence and their combination in patients with HER2/Erb2 positive primary breast cancer - ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study, Study No. BIG2-06/N063D/EGF106708.Erika Matos
MINDACT (Microarray In Node-negative Disease may Avoid Chemotherapy): A prospective, randomized study comparing the 70-gene signature with the common clinical-pathological criteria in selecting patients for adjuvant chemotherapy in node-negative breast cancer. EudraCT številka 2005-002625-31Erika Matos
Preoperative Radiotherapy, Capecitabine (Xeloda) and Bevacizumab (Avastin) in locally advanced rectal cancer: CRAB Phase II studyVaneja Velenik
A randomized, multicenter, phase III open-label study of the efficacy and safety of trastuzumab-MCC-DM1 vs. Capecitabine+lapatinib in patients with HER2-positive locally advanced or metastatic breast cancer who have recieved prior trastuzumab-based therapy-EMILIASimona Borstnar
The influence of pharmacokinetic and pharmacodynamic properties of rituximab on its clinical efficacy in patients with diffuse large B-cell lymphomaBarbara Jezersek Novakovic
Quality of life in patients after combined modality treatment of localy advanced resectable rectal cancerVaneja Velenik
SOLE-A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years prior adjuvant andocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancerSimona Borstnar
Randomised, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)Simona Borstnar
A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube CancersOlga Cerar
Evaluation of small B cell lymphomas in cytopathologyUlrika Klopcic
Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast CancerTanja Marinko
A phase 3, multicenter randomized, double-blind, placebo controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreasJanja Ocvirk
An open-label, multicenter expanded access study of RO5185426 in patients with metastatic melanomaJanja Ocvirk
A phase I-II study of lapatinib and docetaxel as neoadjuvant treatment for HER-2 positive locally advanced/inflammatory or large operable breast cancer (10054) LAPATAXErika Matos
CD64 as an early predictive factor for systemic infection after colorectal carcinoma surgeryMilena Kerin Povsic
Global study to assess the addition of bevacizumab to carboplatin and palitaxel as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma of primary peritoneal carcinomaOlga Cerar
Weekly Docetaxel, Cisplatin, and 5-Fluorouarcil as Initial Therapy for Patients With Advanced Gastric and Esophageal CancerCvetka Grasic Kuhar
Registry of treatment patterns in patients with metastatic castration-resistant prostate cancer (mCRPC) with progression during or after docetaxel-based regimenBostjan Seruga
Program NARAKatja Zupancic


Note: Final versions of clinical studies are filed in the Research and Education Unit of the Institute of Oncology Ljubljana. Should you require detailed information on these studies, kindly contact Ms. Vijoleta Kaluža, e-mail: vkaluza@onko-i.si.



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