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Optical PD-L1 imaging using Quantitative Fluorescence Endoscopy in locally advanced esophageal cancer using durvalumab-680LT: a phase I multicenter feasibility and safety study

This study has been transitioned to CTIS with ID 2024-517258-85-00 check the CTIS register for the current data. The primary objective of this study is to determine the feasibility and safety of quantitative fluorescence endoscopy using the…

daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)

Safety Run-in (SRI) part:To confirm the recommended phase 2 dose (RP2D) of NIS793 or any other investigational drug(s), in combination with SOC anti-cancer therapy. In protocol amendment 1, an arm with tislelizumab has been added. In this arm, the…

Dye chromoENDOscopy versus virtual chromoendoscopy for assessment of the ileo-anal pouch in patients with familial adenomatous POLyposis: a randomized controlled trial

The primary outcome of this study is the detection of clinical relevant adenomas (>= 5mm) in the ileal pouch.

Treatment of PERitoneal dissemination in Stomach Cancer patients with
cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the
PERISCOPE II study

This study has been transitioned to CTIS with ID 2023-510159-53-01 check the CTIS register for the current data. The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis…

COLLISION RELAPSE trial - Recurrent colorectal liver metastases: repeat local treatment +/- neoadjuvant systemic therapy - a phase III prospective randomized controlled trial

This study has been transitioned to CTIS with ID 2024-515341-41-01 check the CTIS register for the current data. The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to…

Real-time use of artificial intelligence (CAD EYE) in the colorectal cancer surveillance of Lynch syndrome patients - an international multicenter trial

Primary Objective:- To compare adenoma detection rate (ADR) with versus without real-time automated detection (CAD EYE, Fujifilm)Secondary Objectives:- To compare the size, morphology and histology of adenomas detected and resected in both arms of…

I CARE STUDY; Improving Care After colon canceR treatment in the Netherlands
- Personalised care to Enhance quality of life -

The above mentioned developments are subject to the I CARE study. We hypothesize that general practitioner (GP) involvement improves both aftercare and preventive care resulting in improved quality of life and patients* satisfaction. Furthermore, a…

A randomized phase II study of pulsatile high-dose sunitinib versus TAS-102 in patients with metastatic colorectal carcinoma (mCRC).

The primary objective is progression-free survival (PFS); defined as the time from randomization to the date of the first documented tumor progression; determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or death due…

The role of surgery of the primary tumour with few or -absent symptoms in patients with synchronous unresectable metastases of colorectal cancer,
a randomized phase III study

The primary objective is overall survival (OS).Secondary objectives are progression free survival (PFS), grade 3 and 4 chemotherapy related toxicity, surgery related morbidity and mortality (30 day and 90 day), quality of life (QoL), number of…

Fluorescence Molecular Endoscopy and Molecular Fluorescence-guided Surgery of locally advanced rectal cancer using cetuximab-IRDye800CW: a single-center feasibility safety study.

The study consists of and endoscopic part (1) and an intraoperative part (2).1) Endoscopic part: to determine the feasibility and safety of molecular fluorescence endoscopy using the fluorescent tracer cetuximab-IRDye800CW targeting the epidermal…

Randomized Multicentre Phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemoradiotherapy and surgery and optional adjuvant chemotherapy (RAPIDO study)

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.…

STOMACH trial: Surgical Technique, Open versus Minimally-invasive gastrectomy After CHemotherapy

Goal of the STOMACH trial (Surgical Technique, Open versus Minimally-invasive gastrectomy After CHemotherapy) is to establish the optimal surgical strategy in the treatment of gastric cancer. A minimally-invasive total gastrectomy will be compared…

Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer

The main objective is to compare overall survival of an active surveillance approach to that of standard surgery for patients with either squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction

Rectal preserving treatment for early rectal cancer. A multi-centred, partially randomised patient preference trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancers.

This study has been transitioned to CTIS with ID 2024-517410-15-01 check the CTIS register for the current data. The aim of this study is to determine the oncological safety, treatment related morbidity, and the functional outcome of local excision…

Identification of risk factors and biomarkers for liver diseases, hepatocellular carcinoma, cholangiocarcinoma and gallbladder carcinoma. The ESCALON stduy.

To investigate different types of biomarkers in blood from patients with a HPB malignancy, HPB related disease as well as from healthy volunteers in order to identify biomarkers that serve as early predictors for the development of HPB malignancies…

CELAC and European consortium for a personalized medicine approach to Gastric Cancer (LEGACy)

Western Management strategies have been ineffective to modify the poor prognosis of GC. This proposal will focus on this specific challenge to *improve GC outcomes*, and will seek to gather evidence through international high-quality translational…

Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer

The OMEGA trial will primarily investigate if omentum preservation (partial omentectomy) during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of three-year overall survival.

Efficiency, safety and feasibility of PerfusiX-Imaging for Gastro-Intestinal tissue perfusion assessment in humans.

The study objective is to evaluate the efficiency of PerfusiX-Imaging compared to the current state of the art for perfusion measurements; indocyanine green fluorescence imaging. Also, feasibility and safety of PerfusiX-Imaging for perfusion…

Rapid on-site evaluation (ROSE) vs. randomly collected samples from mediastinal and abdominal lymph nodes obtained by endoscopic ultrasound-guided fine-needle-aspiration

The goal is to investigate the added value of having a cytotechnician on-site while performing EUS-FNA of a lymph node.

Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA)

To compare MIDP with ODP regarding radical resection rate) for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.