View clinical trials related to Recurrence.
Filter by:It was previously shown that 18F-DOPA PET imaging results in intended management changes in 41% of brain tumor patients. However, its impact on patient outcome defined as survival, costs, and/or quality of life has not been demonstrated. Regulatory agencies require randomized trials to determine the impact of PET on patient management and outcome. In this study we hypothesize that the addition of 18F-DOPA PET will improve patient outcome by more accurately identifying presence or absence of tumor recurrence than conventional imaging.
This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer
Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe to continue NM upon a lapse and that doing so dramatically increases success at quitting. The investigators will test this by doing a randomized trial in which all treatment and measures are done from home with paper, phone or computer surveys. The investigators will recruit smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks of counseling. One group will be asked to stop use of the patch if they lapse and the other group will be asked to continue use of the patch if they lapse. The investigators will compare the groups on their success at quitting and side-effects.
Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical management of men with suspected recurrent prostate cancer post prostatectomy or radiotherapy. We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and will lead to changes in management decisions among men being re-staged for suspected prostate cancer recurrence post-surgery or radiation who are potentially eligible for local salvage therapy.
This study was designed and developed in the Emilia Romania research and innovation program (PRI ER). The study does not have commercial sponsors and comes under the independent studies provided for by Ministerial Decree 17.12.2005. The PRI ER program will guarantee a contribution to the study for the first three years of recruitment through the regional Innovation Fund, to cover the costs of coordination and data management sustained by the Coordinating Center. Primary Objectives The study proposes to evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer with low risk of local recurrence and who undergo conservative surgery, is not inferior to postoperative irradiation with conventional fractionation of the entire breast as regards local control (incidence of ipsilateral recurrences as prime event). Secondary Objectives Comparison of the global survivals, freedom from locoregional recurrences (with exception for contralateral tumors and second tumors), distant relapse-free (except for local or regional relapses or in the contralateral breast) in patients treated with conventional radiotherapy and accelerated partial radiation. To evaluate whether accelerated partial irradiation offers cosmetic results, acute toxicity comparable with conventional irradiation. Possible connection with other national and international studies Similar studies which nonetheless evaluate different methods of partial irradiation are currently underway. Study Design Multicenter phase III controlled randomized, unblinded study of non-inferiority. Number of cases Recruitment of 3302 patients is planned. Target Population of the Study Women aged = > 49, ECOG 0-2, undergoing conservative breast surgery for invasive breast cancer, pT 1-2 (< 3 cm in diameter) pN0-N1 M0, unifocal, resection margins histologically negative (³ 2 mm) at first intervention or after subsequent widening. Duration of the recruitment and of the subsequent follow-up A recruitment of 8 years is planned and a follow-up period of 5 years for an overall duration of the study of 13 years. Treatment The patients will be randomized to receive one of the following treatments: Trial arm 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval of at least 6 hours between the two fractions, for five consecutive working days. Control arm 50.0 Gy in 25 fractions (2 Gy per fraction), once a day for 5 days in the week. Endpoints Primary: survival free of local ipsilateral recurrence as prime event Secondary: global survival, locoregional recurrence-free, distant recurrence-free, acute and late toxicity (RTOG) and cosmetic result. Evaluation and Follow-Up Program Controls are planned during the radiotherapy, at the end of treatment, at 6 weeks, 3-6-12 months from the end of the radiotherapy and then once a year until the end of 5 years. Data Analysis Partial irradiation will be considered not inferior to the standard irradiation if the top extreme of the HR confidence interval at 95% (to endpoint) does not exceed the established value of 1.5 The study was sized in relation to the rate of local ipsilateral breast recurrences as prime event at 5 years and assuming that this rate in the standard treatment group is 4%, accepting as maximum Hazard Ratio inferior to 1.5 and error a and b equal respectively to 0.05 and 0.10 and test at an endpoint. The survivals will be calculated using the Kaplan-Meier method. The hazard ratio (HR) will be calculated using the Cox model and its confidence interval at 95% will be reported. Ethical Aspects and Informed Consent For participation in the study an informed consent is planned appropriately drawn up and submitted to the approval of the Ethics Committees. The clinical study will be carried out according to the ethical principles of the Helsinki Declaration, the GCP guidelines, the Italian laws and regulatory activities for carrying out clinical studies. Before formal commencement of the study its approval/sole opinion by the reference Ethics Committee of the proposing group is stipulated. The individual investigators of the different participating institutions are directly responsible for the submission for approval of the protocol by their Ethics Committees.
Hypothesis: Modulation of central nervous sympathetic activation by administration of moxonidine, a centrally acting medication which decreases the sympathetic nervous system activity, can lead to a decrease in atrial fibrillation recurrence after ablation treatment with pulmonary vein isolation.
Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) >= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.
The purpose of this study is to determine the safety and activity of the investigational drug known as carfilzomib in the treatment of multiple myeloma (MM) when it is given at doses above the usual dose after the standard dosing has become ineffective. The other purpose of this study is to understand what causes the multiple myeloma to become resistant to carfilzomib and whether this can be overcome in the laboratory.
Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing durable responses. However, requiring continuing IM indefinitely and the ability of IM to eradicate the CML clone was uncertain. In a small proportion of patients, IM can induce complete molecular response (CMR) defined by the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The question whether or not these patients are cured and can discontinue drug therapy has been assessed by Mahon and coll, in the STIM study. He demonstrates that IM can be safely discontinued in patient with a CMR of at least 2 year duration and all patients who relapsed after IM discontinuation mainly did it in the first 6 months and responded to reintroduction of imatinib. Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved target specificity over imatinib. Its efficacy and safety in the treatment of patients who are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led to the registration in second and first line treatment of CML-CP patients. Nilotinib produces even faster and deeper responses with more occurrence of CMR than does Imatinib. Consequently, one can assume that a more potent drug such nilotinib could induce deeper and sustained CMR allowing longer period off treatment than IM. The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.
The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our current method of ICE-guided recordings from a conventional mapping catheter with high output pulmonary venous pacing.