18 results
PRIMARY OBJECTIVESThe primary objective of MAKEI V is to assess in a randomized comparison whether the efficacy of Carboplatin (600 mg/m² per cycle) (AUC 7.9 mg/ml/min.) is not inferior to Cisplatin (100 mg/m² per cycle) in malignant GCT (MGCT) of…
The aim of the trial is to individualize treatment for each patient by adapting it to early response and thus to continue intensive treatment only with those patients wo show an inadequate treatment response.For patients who show a good initial…
The objectives of the Phase 1 dose escalation are:Primary Objectives:* To establish the Maximum Tolerated Dose (MTD) and to establish the Recommended Phase 2 Dose (RPTD) for veliparib in combination withcarboplatin and etoposide.* To evaluate the…
Objective of this research is to evaluate whether neo-adjuvant chemo-/radiotherapy in small non-advanced rectal cancers can be used to obtain a complete or near complete remission. In these patients could a complete resection of the rectum as an…
Primary objectives-Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years.-Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an out…
The aim of this trial is to individualize and thus to optimize treatment for each patient by adapting it to the individual response. The treatment response is determined by means of FDG-PET after 2 cycles of escalated BEACOPP + 2 cycles of ABVD.The…
DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild hemophilia A.
Primary objectives:To assess the proportion of non-severe hemophilia A patients within FVIII target levels with the DDAVP and FVIII concentrate combination treatment in the first 72 hours after the start of combination treatment, without adding off-…
The primary objective of this study is to compare, in a randomized phase III trial, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (*3+7*) on OS in older AML patients.
Primary ObjectiveTo evaluate whether lenvatinib in combination with ifosfamide and etoposide (Arm A) is superior to ifosfamide and etoposide (Arm B) in improving progression-free survival (PFS) by independent imaging review [IIR] using Response…
To investigate whether peri-operative dosing using a population-based pharmacokinetic model (non-linear mixed effect modelling) in hemophilia patients leads to a significant reduction in clotting factor consumption in comparison to the standard…
Primary: • To investigate whether adjuvant atezolizumab treatment after standard, concurrent chemo-radiotherapy improves overall survival (OS) compared with no treatment after standard, concurrent chemo-radiotherapy in limited disease SCLC patients.…
Primary objectives Part A:To test the non-inferiority, as evaluated by OS, of three courses of HDCT compared to focal RT plus conventional chemotherapy as consolidation therapy following conventional chemotherapy in children with ATRT aged 12 - 35…
The objective of the induction/consolidation chemotherapy randomisation (R1) is to compare: - VIDE strategy: vincristine, ifosfamide, doxorubicin and etoposide (VIDE) as induction chemotherapy and vincristine, actinomycin D and ifosfamide (VAI),…
To investigate the influence of aprepitant on the exposure to etoposide in TC patients treated with (B)EP.
Primary Objective:- To investigate whether adding TRT to durvalumab plus chemotherapy improves 1-year survival. Secondary Objectives:- To investigate whether adding TRT improves 2-, 3-, 4- and 5-year overall survival.- To investigate whether adding…
The aim of this study is to reduce the indication for RT without compromising cure rates. To investigate if intensified consolidation therapy (DECOPDAC-21) compared to standard consolidation therapy (COPDAC-28) can compensate for reduction in RT.
To investigate wether the treatment of children and adolescents with AML can be improvedby means of:1) improved risk-group adapted treatment2) reduced treatment toxicity through shortened consolidation therapy.
To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly diagnosed stage 4 childhood renal tumours. The MetRR will include the pulmonary response rate (PRR) and the response…