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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
Naslov študije Nosilec IBCSG A randomized trial of axillary dissection versus no axillary dissection for patients with clinically node negative breast cancer and micrometastases in the sentinel node (IBCSG Trial 23-01; Sentinel Lymph Node Biopsy Trial) Janez Žgajnar P3-0003 Development and evaluation of new approaches to cancer treatment Gregor Serša Randomised phase II clinical trial: gemcitabine in brief or long infusion, cisplatin and irradiation for inoperable non-metastatic nonsmall cell lung cancer Matjaž Zwitter Nutrition day in European hospitals Nada 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 cancer Matjaž Zwitter Effect of recombinant human erythropoietin used as supportive care on the properties of cancer tissue of patients with metastatic breast cancer Simona Borštnar Identifying systemic inflammatory response of a cancer patient's organism to an extensive surgical treatment Nada Rotovnik Kozjek A randomized, multi-centre, open label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients
with HER2/Erb2 positive primary breast cancer - ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) studyErika 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 Erika Matos A Phase 3, Randomized, Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine for the Treatment of ErbB-2-Positive Locally Advanced or Metastatic Breast Cancer Erik Škof Treatment of liver metastases with electrochemotherapy Gregor Serša Safety assesment of treatment with bevacizumab in metastatic breast cancer and renal cell carcinoma - eVA Erika Matos Prediction of the aesthetic result in breast cancer conservative treatment Janez Žgajnar 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 received prior trastuzumab-based therapy
(Protocol numbers: TDM4370g/BO21977 - EMILIA)Simona Borštnar 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 RAD001 Compassionate use (protocol RAD001, everolimus) Breda Škrbinc A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer (IBCSG 25-02: TEXT) Erik Škof Cisplatin with either alimta or gemcitabine in long infusion for mesothelioma: a randomised phase II trial (Agili trial) Viljem Kovač MRI assisted cervix cancer brachytherapy pre-planning, based on insertion of the applicator in para-cervical anaesthesia Primož Petrič Identification of Men with a Genetic predisposition to ProstAte Cancer: Targeted screening in BRCA1/2 mutation carriers and controls (The IMPACT study) Janez Žgajnar Safety and efficacy of intratumoural electrotransfer of plasmid AMEP in patients suffering from advanced of metastatic melanoma - an open phase I clinical trial Gregor Serša
Marko SnojEuropean study on MRI-guided brachytherapy in locally advanced cervical cancer-EMBRACE Primož Petrič Chemotherapy induced peripheral neuropathy outcome measures standardisation study Tanja Roš The influence of pharmacokinetic and pharmacodynamic properties of rituximab on its clinical efficacy in patients with diffuse large B-cell lymphoma Barbara Jezeršek Novaković Late effects of adjuvant radiochemotherapy in patients with gastric adenocarcinoma Irena Oblak Radiotherapy plus adjuvant temozolomide in the treatment of lung cancer patients with brain metastases Uroš Smrdel ITAC trial: Intermittent Tki And Chemotherapy for patients with advanced non-small cell lung cancer Matjaž Zwitter SOLE-A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer Coordinating Simona Borštnar A survey of bevacizumab treatment (eVA) for metastatic breast and kidney cancer; the “eVA” survey extended to colorectal cancer Janja Ocvirk Comparison of efficacy of systemic and local pain treatment in patients after operation of breast carcinoma and axillary dissection and after primary reconstruction with tissue expander – a prospective randomized study Branka Stražišar Cancer genetic counselling: knowledge, expectations and attitude among women with familial breast and ovarian cancer Mateja Krajc D-CARE-A Randomized, 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 Simona Borštnar Long- term survivorship in European patients treated for Hodgkin’s lymphoma (EORTC) Radka Tomšič Demšar Evaluation of myocardial damage in breast cancer patients treaded with chemotherapy and trastuzumab Erika Matos A prospective study of determing the clearance of thyroglobulin (Tg) after total thyroidectomy in patients with thyroid carcinoma with Tg antibody and without Tg antibody Nikola Bešić A phase II study evaluating the efficacy and safety of lapatinib + vinorelbine in ErbB2 positive metastatic breast cancer patients after progression of chemotherapy or hormonal treatment in combination with lapatinib for metastatic disease Cvetka Grašič Kuhar Comparison of systemic and local pain treatment in patients after operation of breast carcinoma; a prospective randomized study Branka Stražišar A Multicentre, Single-Arm Open-Label Study of the Repeated Administration of QUTENZA for the Treatment of Peripheral Neuropathic Pain. Short title: STRIDE; Protocol no: E05-CL-3001 Slavica Lahajnar 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 Cancers Olga Cerar Follow-up of patients with non-small cell lung cancer (stage IIIb/IV) treated with erlotinib Matjaž Zwitter An open-label, multicenter expanded access study of RO5185426 in patients with metastatic melanoma (BRAF) Janja Ocvirk Clinical studies with finished enrolment
Naslov študije Nosilec A phase IIIb study of MabThera® (rituximab) maintenance therapy in patients with follicular non-Hodgkin’s lymphoma who have responded to induction therapy (MAXIMA MO19872) Barbara Jezeršek Novaković An open-label randomized phase III study of intermittent oral Capecitabine in combination with intravenous Oxaliplatin versus bolus and continuous infusion of Fluorouracil/Intravenous Leucovorin with intravenous Oxaliplatin as treatment for patients with metastatic colorectal cancer who have received prior treatment with CPT-11 in combination with 5-FU/LV as first-line therapy (NO 16967) Janja Ocvirk Chemotherapy Adjuvant Study for women at advanced age (IBCSG 32-05 CASA) Simona Borštnar COFE – Cooperation of Post menopausal patients with early breast cancer, hormone receptor positive on adjuvant or extended adjuvant therapy with Femara ® Jernej Benedik Quality of life in patients after combined modality treatment of localy advanced resectable rectal cancer Vaneja Velenik Preoperative Radiotherapy, Capecitabine (Xeloda) and Bevacizumab (Avastin) in locally advanced rectal cancer: CRAB Phase II study Vaneja Velenik Randomised double-blind trial in postmenopausal women with primary breast cancer who have received Adjuvant Tamoxifen for 2-3 years,
comparing subsequent Adjuvant Exemestane treatment with further Tamoxifen (96-OEXE 031-C/13/96)Jožica Červek 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 Borštnar 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 Borštnar After Mapping of the Axilla: Radiotherapy or Surgery? (AMAROS EORTC 10981) Marko Snoj Prva, prospektivna, večcentrična raziskava o napovedni vrednosti p53, določenega s funkcionalnim testom na glivah za odgovor na kemoterapijo z ali brez taksanov pri bolnicah z lokalno napredovalim/vnetnim rakom dojke ali pa večjim, operabilnim rakom dojke (EORTC 10994-BIG 00-01) 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 Randomized phase III study of adjuvant chemotherapy followed by adjuvant Tamoxifen versus nil for patients with operable breast cancer (EORTC 10901) Erika Matos Prolonged infusion of Gemcitabine combined with cisplatin for treatement of patients with advanced lung cancer and mesothelioma Matjaž Zwitter A multicenter randomized phase III study to compare capecitabine alone or in combination with trastuzumab in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab (GBG26 MO17038) Erika Matos Prospective, multicenter, randomized, parallel-group, open-label phase II study to investigate the efficacy, safety and tolerability of 2 doses of ZK 219477 (16 and 12 mg/m2 body surface area) in patients with metastatic breast cancer (EPOTILON) Simona Borštnar A SU011248 treatment protocol for patients with cytokine-refractory
metastatic renal cell carcinoma who are ineligible for participation in
other SU011248 protocols and may derive benefit from treatment with SU011248 (SUTENT, Protocol number A6181037)Breda Škrbinc Cetuximab (Erbitux), Capecitabine and radiotherapy in neoadjuvant
treatment of patients with locally advanced resectable rectal cancer: a Phase II Pilot Study (XERT)Vaneja Velenik A multicentre, randomized phase III study of Rituximab as maintenance treatment versus observation alone in patients with aggressive B-cell lymphoma: NHL-13 (NHL 13 ML18223) Barbara Jezeršek Novaković A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX4 + weekly Cetuximab versus FOLFOX4+ bi-weekly Cetuximab as first-line therapy in patients with metastatic colorectal cancer (Protocol CECOG/CORE.1.2.002) Janja Ocvirk PREDICT - Patient characteristics in REnal cell carcinoma and Daily practICe Treatment with Nexavar Breda Škrbinc The presence of opioid receptors in the skin and subcutis in the area of the breast. Nonintervent study-analysis of archival paraffin bioptic samples Branka Stražišar 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 Induction chemotherapy followed by chemoradiation with cetuximab and cisplatin for inoperable squamous-cell carcinoma of the head and neck Primož Strojan Randomized, open-label, phase III trial of Erlotinib alone or in combination with CP-751,871 in patients with advanced non-small cell lung cancer of non-adenocarcinoma histology (ADVIGO, Protocol number A4021018) Branko Zakotnik 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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