27 results
The primary objective of the study is to prospectively determine whether fluoropyrimidine-induced toxicity is preventable by dose adjustment prior to start of the first administration based on the polymorphic status of the DPYD*2A polymorphism in…
Primary Objective: Description of the 1-year overall survival after chemo-radiation therapy with or without panitumumab in irresectable carcinoma of the oesophagus. The control arm is used to validate whether the historical cohort used for…
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…
Primary objective: to detect an increase in progression free survival (PFS*, see chapter 7.3.6) rate at 1 year in each experimental arm (mFOLFOX6 + bevacizumab or panitumumab) compared to mFOLFOX6 alone arm as perioperative treatment for resectable…
The objective of this prospective, observational study is to ensure the safety and the wellbeing of subjects treated with the NEVO* SES.
In Small Cell Lung Cancer patients the purpose of this study is to compare the overall survival of patients on Nivolumab with patients on Topotecan after they have been treated with platinum -based first line chemotherapy.
The objectives are to assess the efficacy, safety and effect on quality of life of Nintedanib compared to chemotherapy in women with relapsed, advanced or metastatic clear cell cancer of the ovary of endometrium.
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.
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…
Phase 1b:Primary:- To evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) and schedule of ALRN-6924 when administered to patients with TP53-mutated extensive disease (ED) small cell lung cancer (SCLC) receiving…
Primary objective:To determine whether there is a difference in overall survival (OS) between lurbinectedin (PM01183)/doxorubicin (DOX) and a control armconsisting of best Investigator's choice between cyclophosphamide (CTX), doxorubicin (DOX)…
This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…
The primary objective of this study is to determine whether the addition of induction chemotherapy to the neoadjuvant treatment of patients with locally recurrent rectal cancer results in more R0 resections compared to treatment with neoadjuvant…
Primary objective:To determine the percentage of the patients that achieve optimal 5-FU exposure within two dose cycles of 5-FU, which is defined by an AUC target of 5-FU between 20 and 30 mg h/L or dose limiting toxicity.Secondary objectives:-To…
Primary Objective• To assess the effect of ALX148 + pembrolizumab + 5FU + platinum on 12-month overall survival (OS) rate and objective response rate (ORR)in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated…
Investigate whether perioperative mFOLFIRINOX improves overall survival compared to adjuvant mFOLFIRINOX in resectable pancreatic cancer.
To determine the median progression-free survival (PFS) and R0/1 secondary resection rate upon induction systemic treatment in colorectal cancer patients with initially unresectable liver-only metastases, stratified by RAS and BRAF tumor mutation…
Primary Objective: - To establish the population range (24-h AUC) of high-dose infusional 5-FU in patients with locally advanced, resectable gastric or gastro-esophageal junction cancer treated with perioperative FLOT.Secondary objectives: - To…
The purpose of this study is to demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in participants with second- or third-line (2L-3L) cervical cancer (Overall Survival-OS)
Primary Objectives:-To evaluate if the treatment of Low Risk HB can be reduced (Group B1)-To compare different induction treatment regimens for Intermediate risk HB (Group C)-To compare different post induction treatment regimens for High Risk HB (…