Editing Trials (Mediterranean Institute of Oncology)

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'''NCTID''': NCT06008691 
 '''Title''': A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice 
 '''Study Summary''': This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice. 
 '''Sponsor''': Fondazione Italiana Linfomi - ETS 
 '''Intervention''': “novel” MAB (alone or in combination) 
 '''Start Date''': 2023-10 
 '''Last Updated''': 2023-08-23 
 '''Number of Patients''': 1500 
 '''Recruitment Status''': NOT_YET_RECRUITING 
 '''Condition''': Non-Hodgkin Lymphoma, B-cell 
'''NCTID''': NCT04891471 
 '''Title''': WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER) 
 '''Study Summary''': This work aims to evaluate neurocognitive performance, daily activity and quality of life and local control among patients with brain metastasis (MBM) ≥ 5 due to solid tumors treated with Stereotactic RadioSurgery (SRS) or Whole Brain RadioTherapy (WBRT). This multicentric randomised controlled trial will be conducted at the Fondazione IOM (Viagrande) in collaboration with REM (Viagrande), Hospital G. Martino (Messina) and Hospital Civico ARNAS (Palermo). It will involve, within 5 years starting from 15 September 2020, the enrollment of 100 patients (50 for each arm) with MBM ≥ 5, age ≥ 18 years, Karnofsky Performance Status (KPS) ≥ 70, life expectancy &gt; 3 months, histological confirmation of primary tumor, with controlled or controllable extracranial disease, baseline Montreal Cognitive Assessment (MoCA) of 20/30, Barthel Activities of Daily Living score 90/100, to be subjected to SRS on each brain lesion by LINAC with monoisocentric technique and non-coplanar arcs (experimental arm) or to WBRT (control arm). The primary endpoints are neurocognitive performance, quality of life and autonomy in daily-life activities variations, the first one assessed by Moca Score and Hopkins Verbal Learning Test - Revised, the second one through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL) and Brain Neoplasm (BN-20) questionnaires, the third one through the Barthel Index, respectively. The secondary endpoints are time to intracranial failure, overall survival, retreatments frequency, acute and late toxicities, KPS decrease. It will be considered significant a statistical difference of at least 29% between the two arms (statistical power of 80% with a significance level of 95%). This trial has been approved by the local ethics committee on July 7th 2020 (record 70). Several studies debate what is the predominant factor accountable for the development of neurocognitive decay among patients undergoing brain irradiation for MBM: radiotherapy, especially if extended to the entire brain, or intracranial disease progression? Answer to this question may come from current opportunity, thanks to recent technological advancement, to treat, with significant time savings, improved patient comfort and at the same time minimizing the dose to healthy brain tissue, Multiple Brain Metastasis simultaneously, otherwise attackable only by panencephalic irradiation. The pursuit of a local control rate comparable to that obtainable with WBRT remains the fundamental prerequisite for the aforementioned related assessments. 
 '''Sponsor''': Mediterranean Institute of Oncology 
 '''Intervention''': Stereotactic RadioTherapy 
 '''Start Date''': 2020-09-15 
 '''Last Updated''': 2023-01-18 
 '''Number of Patients''': 100 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Neurocognitive Deficit 
'''NCTID''': NCT00878709 
 '''Title''': Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer 
 '''Study Summary''': The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab. 
 '''Sponsor''': Puma Biotechnology, Inc. 
 '''Intervention''': neratinib 
 '''Start Date''': 2009-07-09 
 '''Last Updated''': 2021-06-11 
 '''Number of Patients''': 2840 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT01030042 
 '''Title''': Trial Comparing Two Two Sequences of Therapy in Colorectal Metastatic Patients 
 '''Study Summary''': Primary Objectives:  Aim of this study is to compare the efficacy and safety of two different sequences of chemotherapeutic agents in order to optimize the treatment of patients with metastatic colorectal cancer progressed to a first line chemotherapy with FOLFIRI and bevacizumab. Primary endpoint will be overall survival, defined as the time elapsed from the date of randomization to the date of patient death due to any cause, or the last date the patient was known to be alive.  Secondary Objectives Progression free survival, Quality of life, Health resource utilisation and economic evaluation, Toxicity and incidence of adverse events  The study regimen includes:  Strategy A: FOLFOX-4 followed, after progression, by irinotecan/cetuximab Strategy B: irinotecan/cetuximab followed, after progression, by FOLFOX-4 Patients will be randomly assigned to one of the two treatment sequences (with 1:1 ratio) using a block design randomization procedure stratified according to center.  The patient accrual period is planned for approximately 36 months. To assess OS, all pts will be followed for up to 18 months after the last patient is randomised. The maximum estimated study duration is approximately 54 months.All statistical analyses will be based on an intention-to-treat approach. CONSORT rules will be applied to describe study flow and protocol deviations. 
 '''Sponsor''': Gruppo Italiano per lo studio dei Carcinomi dell’Apparato Digerente 
 '''Intervention''': FOLFOX-4 
 '''Start Date''': 2009-09 
 '''Last Updated''': 2015-07-15 
 '''Number of Patients''': 110 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Metastatic Colorectal Cancer 
'''NCTID''': NCT02698410 
 '''Title''': Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors. 
 '''Study Summary''': The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg in combination with Temozolomide in subjects with unresectable advanced neuroendocrine tumours of the lung or thymus as Disease Control Rate at 9 months. 
 '''Sponsor''': Ipsen 
 '''Intervention''': Lanreotide (Autogel formulation) and Temozolomide 
 '''Start Date''': 2016-07 
 '''Last Updated''': 2020-10-01 
 '''Number of Patients''': 40 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Neuroendocrine Tumours 
'''NCTID''': NCT01379976 
 '''Title''': Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer 
 '''Study Summary''': Study objectives Primary: To compare toxicity free survival of patients treated with ALC (acetylcarnitine) plus cisplatin-containing chemotherapy (CHT) versus those treated with placebo plus cisplatin-containing chemotherapy.  Secondary: To compare progression free survival, overall survival, the compliance to treatment, the number of episodes of grade 3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, neurotoxicity, as well as the proportion of patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, neuropathic pain intensity, the clinical signs and/or symptoms (such as burning, numbness, itching, etc.) of the sensorial neuropathy between the two treatment arms. Study design Multicentre, randomised, double-blind, placebo-controlled, phase III, superiority study in patients with advanced or metastatic NSCLC (non small cell lung cancer).  Patients to be screened for study inclusion are those for which the decision to start a cisplatin-containing treatment has been already taken in the context of the clinical practice. The type of cisplatin-based treatment is not fixed, but each single investigator is free to choose for each single patient among those already approved for first line treatment of advanced or metastatic NSCLC.  Patients meeting the eligibility criteria will be randomized with a 1 : 1 ratio to receive ALC + cisplatin-containing CHT or Placebo + cisplatin-containing CHT until patient refusal, disease progression, unacceptable toxicity or death. The study will be conducted in Italy in approximately 20 investigational centers in order to recruit 650-675 subjects over a 30-month period.  Both efficacy and safety data will be collected. Follow-up will be according to the clinical practice. Data capture will continue, for each patient, until death or study closure. 
 '''Sponsor''': Mario Negri Institute for Pharmacological Research 
 '''Intervention''': Acetylcarnitine 
 '''Start Date''': 2011-04 
 '''Last Updated''': 2015-04-24 
 '''Number of Patients''': 107 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Non Small Cell Lung Cancer 
'''NCTID''': NCT05467540 
 '''Title''': SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study 
 '''Study Summary''': SPINERY is a Radiofrequency (RF) device designed for palliative treatment of patients with painful metastatic bone tumors involving vertebral bodies, sacrum, iliac crest and peri-acetabulum.  In particular, SPINERY is conceived for pain reduction in patients affected by metastatic bone tumors involving the vertebral bodies, sacrum, iliac crest and periacetabulum, in patients with indication for Standard Therapy and in patients who have failed, not candidates or refuse Standard Therapy.  Primary objective of the SPARTA Study is to demonstrate that SPINERY RF device is effective in short-term (3 months) pain reduction in patients affected by metastatic bone tumors and to demonstrate that SPINERY RF device is safe in the RF ablation treatment of metastatic bone tumors, without causing device-related adverse events including, in particular, nerve injury.  Primary objective hypothesis will be obtained with Brief Pain Inventory (BPI) scale performance questionnaire in terms of palliative treatment.  Change of Worst Pain Score expressed as average reduction of 2 BPI (Brief Pain Inventory) scores will be calculated as:  μc = worst-pain 3-month - worst-pain baseline  A negative average value for change in pain represents a lowering of the subject’s pain score (an improvement, or reduction in pain) and a positive value represents an increase in the subject’s pain score (a worsening or increase in pain). Worst pain score at the target treatment site will be collected from the BPI in the past 24 hours. 
 '''Sponsor''': Axon srl 
 '''Intervention''': SPINERY 
 '''Start Date''': 2022-07-11 
 '''Last Updated''': 2023-02-01 
 '''Number of Patients''': 52 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Vertebral Metastasis