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An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy (TASCO1 study)

This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…

Pre-operative Decitabine in Colon Cancer: a proof of principle study

The primary objective of the study is to assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment…

Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men

The objective of the current proposal is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and intra-anal high-grade, HPV16 positive AIN, who failed on…

S-1 versus capecitabine in the first line treatment of metastatic colorectal cancer patients, the SALTO randomised phase III study of the Dutch Colorectal Cancer Group. A safety evaluation of oral fluoropyrimidines.

The primary objective is to determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer. Secondary objectives include a comparison of efficacy.

The effect of individualized NUTritional counselling on muscle mass and treatment outcome in patients with metastatic COLOrectal cancer undergoing chemotherapy: the COLONUT study

To study the effect of individualized nutritional counselling compared to usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal cancer during first-line chemotherapy. Secondary, effect on total lean body mass,…

A prospective, multicenter, randomised, open-label, active controlled, 2 parallel groups, phase 3 study to compare the efficay and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imitinib

The objective is to compare the efficacy and safety of masitinib 12 mg/kg/day to sinutinib 50 mg/day

RandomizEd Controlled Trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer.

We study whether addition of a radiation boost to standard chemoradiation in patients with locally advanced rectal cancer increases the complete response rate defined as pathological complete response in those who undergo surgery, or 2-years local…

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

The primary objective of this study is to compare PFS of ramucirumab in combination with capecitabine (or 5-fluorouracil [5-FU]) and cisplatin versus placebo in combination with capecitabine (or 5-FU) and cisplatin as first-line treatment in…

Perioperative selective decontamination of the digestive tract (SDD) in elective colorectal cancer patients: a multicenter randomized clinical trial

The primary objective of this randomized clinical trial is to evaluate if perioperative SDD can reduce anastomotic leakage rate and other infectious complications while thereby simultaneously improving long-term oncological outcome. Secondary…

Follow up and functional outcome of organ saving treatment in patients with good response to neo-adjuvant (chemo)radiation

The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.

Node study: 'Esophageal resection for patients with esophageal cancer and cervical lymph node metastases'

To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases in level III and/ or…

The effects of the proton pump inhibitor esomeprazole on the bioavailability of regorafenib in patients with a metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumour (GIST).

To determine the influence of esomeprazole on the AUC of regorafenib in patients with mCRC or GIST.

Autologous Dendritic Cells Loaded with Allogenic Tumor Lysate for Surgically Resected Pancreatic Cancer Patients (REACtiVe Trial)

To investigate feasibility, safety and toxicity as well as immune-response of an allogeneic tumor cell lysate (PheraLys) loaded onto autologous dendritic cells (MesoPher) in resected pancreatic cancer patients who received adjuvant standard of care…

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

The primary objective of this study is to evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with fibroblast growth factor receptor (FGFR) 2 translocation who have failed at least 1…

Addition of stereotactic radiotherapy to the standard FOLFIRINOX treatment in locally advanced pancreatic cancer patients to determine efficacy and feasability (LAPC-1)

This is a prospective phase II non-randomized single-center study in patients with LAPC. Patients are first treated with up to 8 cycles of FOLFIRINOX, followed by stereotactic radiotherapy for a total dose of 40 Gy in 5 fractions. Due to the known…

A phase Ib/II study on the addition of Nab-paclitaxel (Abraxane) to capecitabine and oxaliplatin in the first-line treatment of metastastasized oesophagogastric carcinoma

Primary objectivePhase 1: To assess the safety and tolerability of Nab-paclitaxel added to oxaliplatin and capecitabine at their currently optimal doses.Phase 2: To determine the anti-tumor activity of Nab-paclitaxel when co-administered with…

Phase I study evaluating indomethacin in combination with platinum-based chemotherapy

Phase I study to investigate safety of the combination indomethacin and two platinum-based chemotherapy regimens in patients with advanced cancers.

Feasibility of breath-hold techniques in irradiation of pancreatic cancer

The measurement of pancreatic tumour motion during end expiratory and end inspiratory breath hold during the preparatory CTscan and three radiation fractions and comparing this with the tumour motion during free breathing. The assessment of the…

A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Corectal Cancer (mCRC) Subjects

PrimaryTo compare progression-free survival (PFS) between tivozanib in combination with mFOLFOX6 and bevacizumab in combination withmFOLFOX6 based on investigator radiological tumor assessmentSecondary• Progression Free Survival (PFS) based on…

Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma using Peri-operative Chemotherapy with additional Pre-operative Combined Radiotherapy and Cetuximab

This study aims at developing a novel strategy to optimise the treatment of oesophageal adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. To improve the outcome of patients with this disease we hypothesize that the…