Search results for "phases"
showing 10 items of 282 documents
Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: A prospective phase II study of the Arbeitsgeme…
2007
Abstract Objective. A multicenter non-randomized phase II study was initiated to evaluate tolerability and efficacy of pegylated liposomal doxorubicin (PLD) in combination with carboplatin in gynecologic malignancies. Methods. One hundred forty women with recurrent or advanced endometrial ( n =31), cervical or vaginal cancer ( n =31), uterine sarcomas ( n =11), or recurrent platinum-sensitive ovarian cancer ( n =67) received six courses of PLD 40 mg/m 2 and carboplatin (AUC 6) every 28 days. Results. Hematological toxicities with NCI-CTC grade 3/4 were anemia in 8%, thrombocytopenia in 14%, neutropenia in 24%, and febrile neutropenia in 2% of 652 cycles. Grade 3/4 non-hematological toxiciti…
Robotic Radical Hysterectomy After Concomitant Chemoradiation in Locally Advanced Cervical Cancer: A Prospective Phase II Study
2016
Study Objective To assess the feasibility of total robotic radical surgery (TRRS) in patients with locally advanced cervical cancer (LACC) who receive chemoradiation therapy (CT/RT). Design A prospective (preplanned) study of a nonrandomized controlled trial (Canadian Task Force classification level 2). Setting Catholic University of the Sacred Hearth, Rome, Italy. Patients Between September 2013 and January 2016, a total of 40 patients with LACC (Fédération Internationale de Gynécologie et d'Obstétrique stage IB2–III) were enrolled in the study. Interventions Robotic radical hysterectomy (RRH) plus pelvic and/or aortic lymphadenectomy was attempted within 6 weeks after CT/RT. The feasibili…
Docetaxel and oxaliplatin in the second-line treatment of platinum-sensitive recurrent ovarian cancer: a phase II study.
2007
ABSTRACT Background A prospective phase II study was conducted to evaluate the efficacy and toxicity of the combination docetaxel (Taxotere) (DTX) and oxaliplatin (OXA) in ovarian cancer patients recurring after a platinum-free interval (PFI) >12 months. Patients and methods DTX, 75 mg/m2, was administered by 60 min i.v. infusion, followed by OXA, 100 mg/m2, given by a 2 h i.v., on day 1 every 21 days. Results From October 2003 to June 2006, 43 ovarian cancer patients were enrolled. Median PFI was 26 months. All patients were available for response evaluation: 17 complete responses and 12 partial responses were registered, for an overall response rate of 67.4%. The median response duration …
Liposomal-encapsulated doxorubicin plus cyclophosphamide as first-line therapy in metastatic breast cancer: a phase II multicentric study
2007
Abstract Background The objective of this study is to evaluate the efficacy and toxicity of the liposome-encapsulated doxorubicin (TLC D-99) plus cyclophosphamide (CTX) as first-line treatment of metastatic breast cancer in light of the potential cardioprotective effect of TLC D-99 as compared with conventional doxorubicin. Materials and methods Sixty-seven patients as defined according Simon's two-stage phase II design were enrolled. They received TLC D-99 at the dosage of 60 mg/m2 plus CTX 600 mg/m2, with cycles repeated every 3 weeks. Cardiac function was assessed by ultrasonography at baseline and every two cycles. Results The principal characteristics of the 67 enrolled patients were a…
Abstract TMP17: Revacept, an Inhibitor of Platelet Adhesion in Patients With Symptomatic Carotid Artery Stenosis. Safety Data From the International …
2020
Introduction: Revacept is a novel vascular lesion-directed inhibitor of platelet adhesion and thrombus formation, exhibiting no effects on the homeostatic functions of circulating platelets. Objective: The effects of Revacept on plaque-mediated thrombosis were investigated in patients with symptomatic stenosis of the internal carotid artery (at least 50%, following ECST-criteria). Methods: Within an international, prospective, multicenter (n=16), randomized trial 158 patients could be randomized to receive placebo, or 40/120 mg Revacept by intravenous infusion over 20 minutes. Cerebrovascular events and cardiovascular complications were followed up to 3 months. Results: 158 patients were f…
TITAFORM - Precision Hot Forming, development of innovative hot-forming processes of aeronautical components in Ti-alloy with low buy/fly ratio: an I…
2012
In the paper the description of the project TITAFORM is provided. The project has been financed on the call "PON Linea 1" of the Italian government and represents an effective example of cooperation between academy and industry. The project is focused on the beta forging and hot stretch forming operations of titanium alloys. �� 2012 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.
Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study.
2018
Splenectomy in addition to immunotherapy with rituximab can provide quick and sometimes durable disease control in patients with splenic marginal zone lymphoma (SMZL). However, systemic chemotherapy is ultimately required in many cases. The BRISMA (Bendamustine-rituximab as first-line treatment of splenic marginal zone lymphoma)/IELSG (International Extranodal Lymphoma Study Group)36 trial is an open-label, single arm phase II study designed by the IELSG in cooperation with the Fondazione Italiana Linfomi and the lymphoma Study Association according to Simon's two-stage method. The primary endpoint was complete response rate. Fifty-six patients with SMZL diagnosis confirmed on central revis…
High Anti-Lymphoma Activity of Bendamustine/Mitoxantrone/Rituximab (BMR) in Rituximab Pretreated Relapsed or Refractory Indolent Lymphomas. A Multice…
2006
Abstract Purpose: Bendamustine is a new anti-lymphoma agent with promising activity. Based on a preceeding phase I study the current trial explored Bendamustine in combination with Mitoxantrone and Rituximab (BMR) in patients with relapsed or refractory indolent lymphomas. Patients and Methods: Patients with relapsed or refractory symptomatic stage III/IV indolent lymphomas with or without prior treatment with Rituximab were eligible. Therapy consisted of Bendamustine 90 mg/m2 days 1+2, Mitoxantrone 10 mg/m2 day 1, Rituximab 375 mg/m2 day 8. Treatment was repeated on day 29 for a total of 4 cycles. Results: Between 04/03 and 07/04 62 patients were recruited from 24 participating institution…
Alemtuzumab Combined with Dexamethasone, Followed By Alemtuzumab Maintenance or Allo-SCT in "ultra High-risk" CLL: Final Results from the CLL2O Phase…
2014
CLL with deletion 17p (17p-) or refractory to fludarabine (F)-based regimens is characterized by poor prognosis. The cooperative French/German CLL2O study aimed at achieving deep and durable response in this population by combining alemtuzumab (A) and dexamethasone (D) induction, followed by consolidation with A maintenance or allogeneic stem-cell transplantation (allo-SCT). Induction treatment consisted of subcutaneous A (30mg, 3x weekly) combined with oral D (40 mg days 1-4 and 15-18), both at 28 day cycles, and prophylactic pegfilgrastim 6 mg on days 1 and 15. If at least SD was achieved after 3 cycles, consolidation was scheduled with either allo-SCT or A maintenance (30mg every 2 weeks…
Alemtuzumab Plus Oral Dexamethasone, Followed by Alemtuzumab Maintenance or Allogeneic Transplantation in Ultra High-Risk CLL: Updated Results From a…
2012
Abstract Abstract 716 CLL patients characterized by 17p-, TP53 mutation or refractoriness to fludarabine (F)-based therapy show a very poor prognosis (“ultra high-risk CLL”). Although alemtuzumab (A) showed efficacy in these cohorts, the rate and duration of remissions remain unsatisfactory. Aim of the CLL2O study was to achieve higher overall response rates (ORR) by adding high-dose dexamethasone (D) to A during induction and investigating the consolidation effect of prolonged A or allogeneic stem-cell transplantation (allo-SCT), respectively. Induction treatment consisted of subcutaneous A, 30 mg weekly × 3 for 28 days, combined with oral D, 40 mg on days 1–4 and 15–18, and prophylactic p…