Trial - Anno 2022
N. |
Titolo |
PI e/o altri docenti coinvolti |
SSD |
Codice EudraCT |
Codice EudraCT |
Codice Clinical Trials.gov |
Eventuale altro codice |
Data di autorizzazione del comitato Etico |
Data di effettivo avvio del Trial |
1 |
Studio retrospettivo-osservazionale per ottimizzare la sequenza di trattamento per il carcinoma della prostata metastatico resistente alla castrazione nel paziente anziano con più di 75 anni e nel paziente con alto volume di malattia |
Prof. Antonio Russo |
MED/06 |
|
SPARTACUSS |
|
|
|
|
2 |
The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC (BURAN) |
Prof. Antonio Russo |
MED/06 |
2019-000790-23 |
AN2025H0301 |
NCT04338399 |
|
14/06/2022 |
25/08/2022 |
3 |
CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy |
Prof. Antonio Russo |
MED/06 |
2021-004593-56 |
CAVE-2 |
NCT05291156 |
|
12/07/2022 |
05/09/2022 |
4 |
A Study of AL102 in Patients With Progressing Desmoid Tumors (RINGSIDE) |
Prof. Antonio Russo |
MED/06 |
2020-005833-34 |
AL-DES-01 |
NCT04871282 |
|
12/12/2022 |
|
5 |
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors |
Prof. Antonio Russo |
MED/06 |
2022-500637-80 |
CGT 9486-21-301 |
NCT05208047 |
|
|
|
6 |
Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma |
Prof. Antonio Russo |
MED/06 |
2019-002521-30 |
HBI-8000-303 |
NCT04674683 |
|
12/07/2022 |
19/10/2022 |
7 |
Studio osservazionale retrospettivo-prospettico su pazienti italiani con melanoma trattati in setting adiuvante nella Cohort MAP per valutare la sopravvivenza libera da recidiva e la sopravvivenza globale Studio MADAM (Maximing ADjuvAnt MAP) |
Prof. Antonio Russo |
MED/06 |
|
CDRB436BIT06 (MADAM) |
|
14/09/2022 |
06/12/2022 |
|
8 |
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. (COLUMBUS-AD) |
Prof. Antonio Russo |
MED/06 |
2021-004310-19 |
W00090GE303 / EORTC-2139-MG |
NCT05270044 |
|
12/07/2022 |
28/11/2022 |
9 |
Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma |
Prof. Antonio Russo |
MED/06 |
2021-002392-20 |
1403-0008 |
NCT05218499 |
|
13/04/2022 |
25/05/2022 |
10 |
Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma (ISG-MCS) |
Prof. Antonio Russo |
MED/06 |
2019-003733-41 |
MCS |
NCT04305548 |
|
12/07/2022 |
02/12/2022 |
11 |
REVERT - taRgeted thErapy for adVanced colorEctal canceR paTients (REVERT) |
Prof. Antonio Russo |
MED/06 |
2020-002533-14 |
REVERT |
NCT05396807 |
|
13/04/2022 |
|
12 |
Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) |
Prof. Andrea Cortegiani |
MED/41 |
2015-002346-14 |
|
|
|
19/10/2022 |
05/01/2023 |
13 |
Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia |
Prof. Andrea Cortegiani Prof. Antonello Giarratano |
MED/41 |
|
NCT05403320 |
|
|
14/06/2022 |
01/07/2022 |
14 |
Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma (PrE0505) |
Prof. Andrea Cortegiani Prof. Antonello Giarratano |
MED/41 |
|
NCTO5089695 |
|
|
15/02/2022 |
03/03/2022 |
Trial - Anno 2021
|
Codice EudraCT |
Codice Clinical Trials.gov |
Eventuale altro codice |
Data di autorizzazione del comitato Etico |
Data avvio |
|
|
|
|
|
|
1 |
|
NCT04834011 |
RACOMERC |
|
2021 |
2 |
|
NCT05072171 |
HERNIA 01_2021 |
|
2021 |
3 |
|
NCT04846283 |
ANASTOMOTICLEAKAGE 01_2021 |
|
2021 |
4 |
|
NCT05036837 |
|
|
|
5 |
|
NCT03805230 |
|
28/04/2021 |
|
6 |
|
NCT04165369 |
|
30/12/2020 |
2021 |
8 |
|
NCT02735707 |
|
07/06/2021 |
|
9 |
FIReNEN Study |
|
|
15/12/2021 |
|
10 |
MGMT |
|
|
15/09/2021 |
|
11 |
TOMAS2 |
|
|
20/01/2021 |
10/02/2022 |
12 |
ITANET Registry |
|
|
13/10/2021 |
|
13 |
CABOTEM |
|
|
24/02/2021 |
28/07/2021 |
14 |
RAIN-3201 |
|
2021-001394-23 |
13/10/2021 |
10/02/2022 |
15 |
CAPRI-2 |
|
EUDRACT: 2021-003008-15 |
21/06/2021 |
15/09/2021 |
16 |
ELENA |
|
|
28/04/2021 |
|
17 |
ANASTASE |
|
|
21/07/2021 |
|
18 |
HERMIONE 10 |
|
|
21/07/2021 |
|
19 |
CARE |
|
|
24/02/2021 |
|
20 |
ITALYNCH |
|
|
28/04/2021 |
28/02/2022 |
Trial - Anno 2020
Codice EudraCT |
Codice Clinical Trials.gov |
Eventuale altro codice |
Data di autorizzazione del comitato Etico |
|
1 |
|
|
DRKS-ID: |
16/12/2020 |
2 |
CAPLAND |
|
|
22/04/2020 |
3 |
PANHER |
|
|
23/09/2020 |
4 |
SURVIVOR20 |
|
|
18/12/2020 |
5 |
AMETISTA |
|
|
23/09/2020 |
6 |
HERMIONE 7 |
|
|
16/03/2020 |
7 |
VECODUE |
|
|
24/06/2020 |
8 |
|
NCT04655638 |
|
19/01/2020 |
Trial clinici
Vari componenti del Dipartimento risultano responsabili di trial clinici (>30) con autorizzazione da ECA Policlinico PA.
Istruzioni e modulo di registrazione studio clinico su ClinicalTrials.gov
Modulo di trasmissione (riservato al personale afferente al Dip. Dichirons) di dati relativa a Trial clinici a U.O. Ricerca e TM
SSD MED/18 - Chirurgia Generale
|
|
TITOLO DEL PROTOCOLLO |
PATOLOGIE |
trial monocentrico 'Drainage Fluid Biomarkers and Anastomotic Leakage in Colorectal Surgery. A Monocentric Prospective Observational Study (ALbiomarkers)' Anastomotic leakage (AL) is one of the most feared intra-abdominal septic complications (IASC) after colorectal surgery. It is defined as the leak of intestinal content due to an anastomotic dehiscence. Incidence ranges from 2% to 20%. AL is usually associated to systemic inflammatory response, even if in some cases the presentation may be subclinical. Therefore, AL is suspected in patients with a strong inflammatory response and can be confirmed by imaging with contrast enhanced computed tomography (CT) scan or water-soluble contrast studies. Nevertheless, imaging has varying sensitivity and specificity and is usually performed once the patient has a clinical evidence, thus potentially delaying the correct timing for surgery. Despite several studies about this topic and the plenty of known risk factors as mentioned above, AL is still not easy to predict. Different tools other than imaging have been studied in order to make diagnosis of AL at an early stage, as the measurement of some biomarkers of inflammation in serum and in drainage fluid. Biomarkers as white cell blood count (WBC), C-reactive protein (CRP), cytokines (e.g. TNFa, IL-6, IL-1b), markers of ischemia (e.g. lactate) and procalcitonin (PCT) have been used for an early detection of AL and other intra-abdominal septic complications. The primary aim of our study was to assess the role of drainage fluid CRP and lactate-dehydrogenase (LDH) in the early detection of anastomotic leakage. Codice Clinical Trials: NCT04846283
Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo |
Anastomotic Leakage |
trial monocentrico 'Radiologic Assessment in Complete Mesocolic Excision for Right Colon Cancer (RACOMERC) (RACOMERC)' Colorectal surgery has made progressive advances in recent years related on one hand to the implementation of diagnostic methods that allow an early diagnosis of tumors and on the other hand to the development of therapeutic options based on laparoscopic surgery. In particular, multicenter clinical trials have shown that the laparoscopic approach to colorectal cancer had a comparable or even better outcomes in terms of perioperative complications and functional recovery of patients than traditional surgery. Complete Mesocolic Excision (CME) in right colonic resections is a surgical approach, of greater technical complexity, that appears to improve the oncological outcomes of these patients at the cost of an increased rate of complications. The highest rate of complications reported in the literature in patients undergoing CME was related to intraoperative bleeding due to the central vascular dissection that is performed. CT technological advances have made possible to perform CT angiography with multiplanar and three-dimensional reconstructions with the possibility of obtaining a detailed preoperative map of the vascular anatomy of these patients. CT scan was acquired immediately before contrast material injection and during arterial and venous phase. Arterial phase was obtained using the bolus tracking technique with an automated scan-triggering software. Image analysis was performed using multiplanar reformations (MPR), maximum intensity projection (MIP) and 3D volume rendering (VR) technique. The purpose of the CT was to identify three different parameters necessary for proper performance of CME and CVL and to compare preoperative observations with intraoperative evidence. All surgeries were performed by teams experienced in laparoscopic colorectal surgery. The investigators evaluated:- Fascia of Fredet; vascular structures; lymph nodes. Codice Clinical Trials: NCT04834011
Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo |
Right-sided Colon Cancer |
trial multicentrico 'Laparoscopic Hernia Defect Obliteration With ProFlor-E' This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect. The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept. Codice Clinical Trials: NCT04718298 First Posted : August 31, 2018 Centro coordinatore: University of Cagliari Principal Investigatore per il centro AOU Policlinico Paolo Giaccone: prof. Attilio Ignazio Lo Monte |
Inguinal Hernia |
trial monocentrico 'Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus' Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus. Codice Clinical Trials: NCT01869231
Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo |
Post-operative Ileus |
trial monocentrico 'Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures' Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal sphincter resting pressure. No studies have investigated a possible role of FH in anal fissures (AF). We aim to evaluate the effectiveness of a diet in curing AF and the clinical effects of a double-blind placebo controlled (DBPC) challenge with cow's milk protein or wheat. Codice Clinical Trials: NCT01637857
Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo |
Anal Fissures Treatment and Oligoantigenic Diet |
SSD MED/41 - Anestesiologia
|
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TITOLO DEL PROTOCOLLO |
PATOLOGIE |
trial multicentrico 'Efficacia del rimpiazzo volemico con albumina e soluzioni bilanciate cristalloidi in pazienti con shock settico (studio albioss-balanced)' Si tratta di un trial randomizzato controllato multicentrico fattoriale 2X2, approvato e supportato da AIFA, Eudract registrated. Eudract number: 2018-001582-16 Codice Clinical Trials: NCT03654001 First Posted : August 31, 2018 Registro Studi Clinici Mario Negri Gli obiettivi dello studio sono valutare se 1) la somministrazione di albumina in aggiunta a cristalloidi, rispetto all’utilizzo dei soli cristalloidi riduce la mortalità a 90 giorni (Obiettivo 1); l’utilizzo di soluzioni cristalloidi bilanciate (BAL) riduce la mortalità a 90 giorni o l’incidenza di insufficienza renale acuta, rispetto all’utilizzo di Soluzione Fisiologica (NS) (Obiettivo 2). Centro coordinatore: IRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI - FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO |
Septic Shock |
SSD MED/49 - Scienze tecniche dietetiche applicate
|
|
TITOLO DEL PROTOCOLLO |
PATOLOGIE |
trial monocentrico 'BRCA Main Home Nutritional Intervention-random Study' Women carrying harmful mutation in BRCA1 or BRCA2 gene are at higher risk to develop breast and/or ovarian cancer than the general population. Many observations lead to the hypothesis that breast cancer risk may be increased in women with elevated plasma insulin-like growth factor 1 (IGF-1) and insulin levels. Targeting the IGF system is therefore a promising anticancer therapy and a new tool for oncologists. Evidence from bio-gerontology research from our laboratories show that cycles of short-term fasting/starvation (STS) or low calorie diet can improve health span of laboratory animals, whose effect is partly mediated by reduced circulating IGF-1. Investigators in our group have demonstrated that protein consumption, especially animal proteins, increases IGF-1 level and is associated with elevated cancer risk in a US cohort ranging from age 50 to 65 (PMID: 26094889). It was also showed that alternating prolonged fasting and nutrient-rich medium extended yeast lifespan independently of the status of the established pro-longevity genes. Prolonged Fasting (PF) has also been shown in preliminary studies to decrease the side effects of chemotherapy, an effect now being tested in multiple larger randomized clinical trials (PMID: 26590477). The main hypothesis of this proposal is that a combination of protein restriction, fasting, fasting mimicking diet (FMD), and restriction of specific amino acids may be able to decrease cancer incidence in a cohort of people at high risk of developing tumors (BRCA1/2). Our group plan to verify the safety, effectiveness and impact of a specially formulated longevity dietary regimen (low protein fish- and plant-based) and of FMD repeated cycles on the levels of endogenous hormones in a cohort of people at increased cancer risk. Since the duration of the project will not give us the opportunity to directly measure cancer incidence in humans we will test: 1a) the variation of a number of widely recognized susceptibility biomarkers predictive of cancer incidence in a cohort human carriers of BRCA1/2 mutations in response to the dietary interventions; 1b) cancer incidence and progression in genetically engineered mice (K14Cre Brca1flox/flox Trp53+/flox and K14Cre Brca1+/flox Trp53-/- mice) predisposed to develop hereditary breast cancer in response to corresponding dietary interventions. Investigators will also test epigenetic alterations associated with these interventions in: 2a) DNA samples from muscle biopsies of a subgroup of humans; 2b) breast epithelial tissue in mice.
Codice Clinical Trials: NCT03570125 First Posted : June 26, 2018 Centro coordinatore: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo |
BRCA1 Mutation BRCA2 Mutation |
SSD MED/06 - Oncologia Medica
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TITOLO DEL PROTOCOLLO |
PATOLOGIE |
trial multicentrico 'Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma (ISG-MCS)' Prospective, uncontrolled, multicenter, Italian, investigator-initiated, phase II clinical study to explore the activity of trabectedin in a population of patients aged ≥16 years with progressive, advanced (locally advanced or metastatic), HEY1-NCOA2 positive MCS) , pre-treated with anthracycline-based chemotherapy.
Codice Clinical Trials: NCT04305548 First Posted : March 12, 2020 Centro coordinatore: Italian Sarcoma Group Principal Investigator: Silvia Stacchiotti, MD Fondazione IRCCS INT di Milano Principal Investigator per il centro AOU Policlinico Paolo Giaccone: Giuseppe Badalamenti, MD |
Mesenchymal Chondrosarcoma |
trial multicentrico 'Eribulin in Advanced Solitary Fibrous Tumor (ERASING)' This is an Italian, non randomized, open label, multi center, investigator-initiated, Phase II, clinical study to explore the activity of eribulin in a population of patients with progressive, advanced (i.e. locally advanced or metastatic), molecularly proven SFT. Patients with a documented and centrally reviewed pathological diagnosis of locally advanced or metastatic SFT, and with an evidence of progression within the previous 6 months, may enter the study. Study treatments will be administered till progression or toxicity. The primary end-point of the study is overall response rate Secondary end-points are Progression Free Survival (PFS), Overall Survival (OS) clinical benefit rate, response rate as by Choi criteria, duration of response. Subjects already treated with one or two prior medical therapy regimens for the advanced phase, whatever agent used in first- or second-line, are eligible for inclusion in the study. Investigators will consider eligible for this study even patients naïve from chemotherapy, considering the limited activity of anthracycline in the disease.
Codice Clinical Trials: NCT03840772 First Posted : February 15, 2019 Centro coordinatore: Italian Sarcoma Group Principal Investigator: Silvia Stacchiotti, MD Fondazione IRCCS INT di Milano Principal Investigator per il centro AOU Policlinico Paolo Giaccone: Giuseppe Badalamenti, MD |
Solitary Fibrous Tumor |
trial multicentrico 'A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)' This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off). Codice Clinical Trials: NCT03673501 First Posted : September 17, 2018 Centro coordinatore: Deciphera Pharmaceuticals LLC Principal Investigator per il centro AOU Policlinico Paolo Giaccone: Giuseppe Badalamenti, MD |
Gastrointestinal Stromal Tumors |
trial multicentrico 'Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor (STRADA)' Patients with solitary fibrous tumor will be randomized to receive 6 cycles of trabectedin or doxorubicin plus dacarbazine. In case of progression or unacceptable toxicity while under the experimental treatment prior to the completion of the 6 cycles, the patients will be offered to cross to the other arm (trabectedin arm to doxorubicin plus dacarbazine arm and vice versa).
Codice Clinical Trials: NCT03023124 First Posted : January 18, 2017 Centro coordinatore: Fondazione IRCCS Istituto Nazionale dei Tumori Principal Investigator: Silvia Stacchiotti, MD Fondazione IRCCS INT di Milano Principal Investigator per il centro AOU Policlinico Paolo Giaccone: Giuseppe Badalamenti, MD |
Solitary Fibrous Tumor |
SSD MED/06 - Oncologia Medica |
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TITOLO DEL PROTOCOLLO | PATOLOGIE | ||||||
A Phase 2, open label, multicenter, single arm trial evaluating the activity and safety of Abemaciclib + Aromatase Inhibitors (AIs) after 1st-line treatment with High-Dose Fulvestrant in Hormone-Receptor-Positive (HR+), Human-Epidermal-Growth-factor-negative (HER2-) advanced breast cancer patients The HERMIONE-7 trial
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Neoplasie della mammella | ||||||
A Phase II Study of Pembrolizumab Plus Carboplatin in BRCA-related Metastatic Breast Cancer - PEMBRACA
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Neoplasie della mammella | ||||||
A-BRAVE-Trial - Studio randomizzato di fase III sull’utilizzo dell’anticorpo anti-PDL1 Avelumab come trattamento adiuvante o post-neodiuvante per pazienti con carcinoma mammario triplo-negativo ad alto rischio.
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Neoplasie della mammella | ||||||
Diagnosi e trattamento del carcinoma mammario in Italia: studio osservazionale prospettico nazionale AIOM – Studio BRIDE
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Neoplasie della mammella | ||||||
Fulvestrant seguito da everolimus più exemestane confrontato con exemestane più everolimus seguiti da fulvestrant in donne in postmenopausa affette da carcinoma mammario localmente avanzato o metastatico, positivo per l’espressione dei recettori ormonali (HR+) e negativo per quella del recettore del fattore di crescita epidermico tipo 2 (HER2-), precedentemente trattate con inibitori dell’aromatasi non steroidei (NSAI): uno studio multicentrico di fase III. GIM16-FEVEX
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Neoplasie della mammella | ||||||
MILES-5 – A randomized phase 2 study comparing immunotherapy with chemotherapy in the treatment of elderly patients with advanced NSCLC
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Neoplasie del polmone | ||||||
REGISTRO NAZIONALE DELLE MUTAZIONI “ACTIONABLE” STUDIO “RATIONAL”
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Neoplasie del polmone, Tumori del colon retto, Melanoma, Altre neoplasie |
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Seconda Linea nei Carcinomi Neuroendocrini: Captem o folfiri. Studio clinico randomizzato di Fase II e analisi esplorativa sul ruolo predittivo della PET e dei biomarcatori (studio SENECA)
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Tumori neuroendocrini | ||||||
SQUINT (Squamous Immunotherapy Nivolumab-Ipilimumab Trial): Studio in aperto, randomizzato, di fase II su Nivolumab più Ipilimumab versus chemioterapia a base di Platino in pazienti affetti da carcinoma polmonare a cellule squamose metastatico o recidivante (SqLC) non pretrattati con chemioterapia
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Neoplasie del polmone | ||||||
Studio multicentrico di fase II non randomizzato a braccio singolo su Regorafenib come trattamento di prima linea, in Pazienti affetti da GIST KIT/PDGFRA Wild Type in fase metastatica o non operabile
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Sarcomi dei tessuti molli e gist | ||||||
Studio multicentrico, non interventistico, mirato a valutare l’attività fisica, l’incidenza dei sanguinamenti e la qualità della vita, nei pazienti con emofilia A senza inibitori in un regime di trattamento da pratica clinica - ML40983
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Altre neoplasie | ||||||
Studio Osservazionale sul Sarcoma Epitelioide - EPISObs
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Sarcomi dei tessuti molli e gist | ||||||
Studio osservazionale, prospettico di valutazione dell'attività clinica e della tollerabilità della combinazione Ribociclib + Letrozolo in pazienti con carcinoma mammario avanzato HR+ (HERMIONE-8)
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Neoplasie della mammella | ||||||
Terapia di mantenimento con Trabectedina dopo terapia di combinazione con Doxorubicina Liposomiale e Trabectedina verso terapia di combinazione con Doxorubicina Liposomiale e Trabectedina in pazienti affetti da carcinoma ovarico recidivato tra 6 e 12 mesi dopo chemioterapia a base di platino - TRAMANT-01
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Tumori dell’ovaio | ||||||
Tumore Fibroso Solitario: studio di fase II con Trabectedina versus adriamicina in combinazione con Dacarbazina nella malattia avanzata - STRADA
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Sarcomi dei tessuti molli e gist | ||||||
Tumore Fibroso Solitario: studio di fase II su eribulina in pazienti con malattia avanzata (ERASING)
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Sarcomi dei tessuti molli e gist |