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A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer.

The main purpose of this study is to determine the side effects of trastuzumab when it is given by each of these subcutaneous injection methods. The study will also gather information about whether and when the cancer comes back after taking…

Discrimination of benign and malignant human tissue during percutaneous interventions using optical spectroscopy techniques

In our previous studies using optical spectroscopy, both ex vivo and in vivo, most promising results were obtained for tissue diagnosis. Moreover, invasive procedures for biopsy or radiofrequency ablation in these tissues are all very common. Thus,…

Fast-track thyroidectomy and I-131 radioiodine ablation therapy in patients with differentiated thyroid cancer.

Firstly, to study the reduction in sick-leave time achieved by the treatment protocol. Secondly to study the quality of life in the patients treated in the fast-track protocol, to study the reduction in societal costs and to stdy the efficacy of a…

A multicentre, open label, randomized Phase II trial of the MEK inhibitor pimasertib or dacarbazine in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma

Primary objectiveTo compare the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine.Secondary objectivesEfficacy- To compare the objective response of subjects treated with either pimasertib or dacarbazine.- To…

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

Primary Objective: To compare overall survival (OS) of subjects randomized to ipilimumab in addition toplatinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum andetoposide (Arm B) in subjects with newly…

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

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients with Advanced Cancer.

Primary objective* To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).* To assess biological activities of SAR405838 in patients with dedifferentiated liposarcoma…

A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.
The ReCab trial

Primary objectives:To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with Cabazitaxel in order to proceed with a Randomised Phase 2 trial designed to determine the clinical value of Rhenium-…

A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment

Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…

A randomized study with cisplatinum concomitant with standard or adaptive high dose radiotherapy for advanced head and neck cancer.

The most important questions of this phase III trial is:Can adaptive high dose radiotherapy improve loco-regional control without increase of toxicity?

Infusion of IL-15 activated NK cells after allogeneic stem cell transplantation in children transplanted for relapsed/refractory leukemia: a feasibility study

Primary: The main objective of the study is to evaluate the feasibility, safety and tolerability of allogeneic IL15-activated NK cell infusions in children transplanted for refractory or relapsed leukemia.Secondary: To document immune reconstitution…

Non-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset.

The aim of this pilot-study is to examine the accuracy of MRL compared to current nodal staging methods. We expect anacceptable accuracy of the MRL based on earlier studies with gadofosveset enhanced MRI in rectum cancer patients. Then the MRL could…

A phase II prospective imaging study evaluating the utility of pre-treatment zirconium-89 labelled trastuzumab PET/CT and an early FDG-PET/CT response to identify patients with advanced HER-2 positive breast cancer unlikely to benefit from a novel anti-HER2 therapy: T-DM1

The primary objective (on lesion-based analysis) is to show that pre-treatment 89Zr-trastuzumab PET/CT is able to select lesions not responding morphologically from treatment with T-DM1 (applying RECIST 1.0 criteria)Secondary Objectives and…

The effects of a yoga-based stress reduction program on fatigue and quality of life in women with chemotherapy for breast cancer: a mono-centre, pragmatic, randomized clinical study

To investigate whether an adjunctive YBSR program added to standard care compared to standard care alone, can reduce:1.fatigue symptoms (primary objective)2.psychological distressand improve:3.health-related quality of life4.sense of coherence5.…

Change of body composition in breast cancer: All-in Assessment

The aims of this project are to:1. Assess what percentage of breast cancer patients experience accelerated gain in fat mass, loss of muscle mass and muscle strength as induced during chemotherapy2. Assess whether changes in energy intake, protein…

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

Efficacy ObjectivesThe primary efficacy objective of study GO28141 is as follows:* To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive…

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…

Age-related changes of the immune system leading to hyporesponsiveness; a major player and predictor for biological behaviour of metastasized melanoma?

To study the frequencies and differentiation status of CD4 and CD8 T cell populations (Tnaive, TCM, TEM, TEMRA) in young (18-50) and old (>65) treatment naive metastasized melanoma patients at baseline and after treatment.

Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib followed by sorafenib in the treatment of advanced / metastatic renal cell carcinoma

Primary:To evaluate if progression-free survival from randomization to progression or death during second-line therapy (total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib.Secondary:1. Time from…

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.