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A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

This study has been transitioned to CTIS with ID 2024-513513-12-00 check the CTIS register for the current data. Primary ObjectivesEvaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants…

the Application of Exhaled breath aNalysis in the Early detection of ASpergillosis

To determine the accuracy with which patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls can be discriminated from each other, as measured by the values of the sensitivity, specificity and accuracy.

Radioembolization with 166Ho-microspheres in elderly and/or fragile patients with previously untreated unresectable liver-only metastases of colorectal cancer, CAIRO7 study endorsed by the Dutch Colorectal Cancer Group (DCCG)

Primary objective:The objective of this randomized phase 2 study is to demonstrate efficacy of RE in terms of PFS in colorectal cancer patients with liver-only metastases who are candidates for palliative systemic treatment with capecitabine plus…

Pre- and postoperative energy expenditure in major liver resection: what do we ask from a patient?

The aim of the study is to gain more insights into the metabolic demand and possible changes thereof pre- and postoperatively. Additionally, data on aerobic fitness and activity levels will be gathered.

External validation of the beta-lactam target non-attainment (BATMAN) risk score in adult ICU patients: a diagnostic multivariate predictive risk model

The primary objective is an external validation of the beta-lactam target non-attainment (BATMAN) risk score, a four-routinely available prediction model in adult critically ill patients with a convenient scoring system in Dutch hospitals.

The efficacy of a lock solution containing taurolidine, citrate and heparin for the prevention of tunneled central line-associated bloodstream infections in pediatric oncology patients, a randomized controlled, mono-center trial.

To determine wheter the use of the taurolidine 1.35%, citrate 4%, and heparin 100 IU/ml lock solution (TauroLock*-Hep100) reduces the incidence of first tunneled central line associated bloodstream inections (CLABSI) compared to the heparin 100 IU/…

PROspective Multi-center study to Evaluate the correlation between safety margin and local recurrence after THErmal ablation USing image co-registration in patients with hepatocellular carcinoma (PROMETHEUS-study)

Over recent years, post-processing software has become available that allows co-registration of pre- and post-ablation CECT. This allows three-dimensional quantitative assessment of ablation margins. Such quantification of ablation margin would…

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

The primary objective of this study is to evaluate the efficacy of cabozantinib in combination with atezolizumab versus sorafenib in subjects with advanced HCC who have not received previous systemic anticancer therapy. An secondary objective is to…

Dose individualization of Antibiotics in ICU patients: to TDM or not to TDM and the effects on outcome (DOLPHIN-trial)

The aim of this trial is to evaluate a new early dosage adjustment strategy (TDM) of beta-lactam and fluoroquinolones in adult ICU patients to achieve the adequate pharmacodynamic targets (PDT), compared to the usual treatment strategy.

Single-arm, phase II trial of trifluridine/tipiracil (FTD-TPI), bevacizumab, and individualized radioembolization with 166Ho-microspheres in refractory metastatic colorectal cancer.

To determine safety, tolerability, and activity of individualized radioembolization with 166Ho-microspheres combined with FTD-TPI and bevacizumab.

3D preoperative liver resection planning and confirmation

To assess the feasibility of CT based 3D preoperative resection planning for hepatectomy and postoperative resection confirmation through image fusion of pre- and postoperative 3D CT reconstructions.

Hepatic arterial infusion PUMP chemotherapy combined with systemic therapy versus systemic therapy alone as Induction Therapy for initially unresectable colorectal liver metastases: a randomised controlled trial

The main objective of this trial is to investigate whether HAIP with concomitant systemic therapy prolongs overall survival in chemo-naive patients with initially unresectable synchronous colorectal liver metastases as compared with systemic therapy…

aCcelerated erAS carE for minor and major liver surgery: the CHASE liver study

The aim of this study is to investigate the feasibility and safety of an accelerated protocol for patients undergoing liver surgery compared to a retrospective cohort of patients who followed the standard ERAS care for liver surgery. In this…

Perivascular and peribiliary colorectal liver metastases (0-5 cm): irreversible electroporation versus stereotactic body radiotherapy.

The primary objective of this study is to compare efficacy of IRE to the efficacy of SBRT regarding the primary endpoint (local control at 2 years) in patients with perivascular and peribiliary CRLM (0-5 cm). The CRLM are unsuitable for surgery and…

Stereotactic body radiation therapy after chemotherapy for unresectable perihilar cholangiocarcinoma: a multicenter phase II trial (The STRONG 2 trial)

To evaluate the efficacy of SBRT as additional treatment after standard care chemotherapy regarding tumor local control, toxicity, progression-free survival, overall survival and quality of life. In addition, to explore the value of immunodynamics…

A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

This study has been transitioned to CTIS with ID 2024-518065-10-00 check the CTIS register for the current data. The aim of the study is to demonstrate that HAI P chemotherapy is an effective treatment for unresectable intrahepatic…

Addition of GAAD score to imaging surveillance for early identification of liver cancer.

To study the impact of addition of the GAAD score to imaging in patients with chronic liver disease eligible for HCC surveillance.

Recovery after community acquired pneumonia in children: The short and long-term consequences

Primary objective:- To study the impact of community acquired pneumonia in children on persistent symptoms and quality of life, from admission in hospital until one year after discharge.Secondary objectives:To investigate/assess:- The association…

Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple procedure (SPARROW): a multicenter, randomized controlled trial

This study has been transitioned to CTIS with ID 2024-510766-16-00 check the CTIS register for the current data. This trial evaluates the additional value of pre-emptive antibiotic treatment on clinically relevant OSIs in patients undergoing…

Individualized dosimetry for holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: iHEPAR

Primary objective:To establish the safety and toxicity profile of individualized 166Ho-RE in patients with hepatocellular carcinoma. Secondary objectives:• To evaluate efficacy of individualized 166Ho-RE.• To evaluate biodistribution / dosimetry.•…