42 results
Primary objectiveTo evaluate if BRV influences the psychomotor and cognitive impairing effects of ethanolSecondary objectivesTo evaluate the potential PK interactions between BRV and ethanolTo evaluate the safety and tolerability of co-…
To investigate wether neo-adjuvant chemotherapy followed by cytoreductive syurgery and hyperthermic chemotherapy is feasible and reduces the number of irresectable patients with acceptable morbidity and mortality rates.
* The primary objective of this study is:- the study of the response rate and the macroscopic and microscopic response charactheristics of neo-adjuvant chemotherapy of patients with peritoneal carcinomatosis (PC) of colorectal origin. * Secundary…
Firstly, determination of the maximum tolerated dose (MTD) , dose limiting toxicity (DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin and melphalan.Secondly, evaluation of toxicity, tumor response and survival after IHP…
The primary objective of the study is assessment of the dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of docetaxel, oxaliplatin and capecitabine given in combination in patients with advanced cancer of the stomach or the gastro-…
To assess the response rate to the combination of gemcitabin plus oxlaiplatin in 5 different strata of relapsed/refractory pediatric solid tumors, in whom standard treatment has failed. Secondary objectives are the safety, the duration of response,…
The purpose of the study is to delineate the upstaging percentage of pN0 patients by detection of micrometastases (pN0micro+) and evaluate the benefits from adjuvant chemotherapy on disease recurrence in pN0micro+ CC patients.
To evaluate the efficacy of BRV at the doses of 20, 50 and 100 mg/day in b.i.d. administration in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite optimal treatment with 1 to 2 concomitant AED(s),…
To evaluate the efficacy of BRV at doses of 100 and 200mg/day compared to PBO as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant AEDsTo assess…
Primary: Progression free survival.Secondary: Toxicity, overall survival, response rate, duration of response, translational research.
To determine the safety, feasibility, and tolerability of adding PIPAC with oxaliplatin (92 mg/m2) to systemic chemotherapy in patients with isolated PM from CRC.
To assess the safety and feasibility of a multimodal combination of FLOT CT with CROSS
To prospectively explore the feasibility safety, tolerability, preliminary efficacy, costs, and pharmacokinetic profile of repetitive ePIPAC-OX as a palliative monotherapy for isolated unresectable colorectal PM under controlled circumstances.
This study has the purpose to assess the pharmacokinetic (the science determining the fate of substances administered to the human body), safety and efficacy of brivaracetam (the study drug) in neonates who have seizures that are not adequately…
Primary objective: To explore the safety and feasibility of neoadjuvant capecitabine, oxaliplatin, docetaxel, and atezolizumab in GE-junction and gastric adenocarcinoma Secondary objectives: • To assess pathological tumor regression and rates of…
Primary objective* To document the long-term safety and tolerability of BRVSecondary objective* To assess the efficacy of BRV during long-term exposureOther objectives* To explore direct cost parameters* To assess the effect of BRV on behavior using…
Phase I study to investigate safety of the combination indomethacin and two platinum-based chemotherapy regimens in patients with advanced cancers.
The primary objective is to assess the feasibility of administering adjuvant S-1 and oxaliplatin in patients with esophageal cancer after neoadjuvant chemoradiotherapy with paclitaxel and carboplatin and esophagectomy
Primary Objective: disease related treatment failure.Secondary Objectives: Overall survival, CRM negative (margin > 1 mm) rate, Pathological complete response (pCR) rate, Short and long-term toxicity, Surgical complications, Quality of life.…
The primary study objective is to compare the efficacy, as assessed by overall survival, of surgery and neo-adjuvant chemotherapy to surgery alone in patients with resectable liver metastases of colorectal cancer and a high clinical risk score.…