Trials

Clinically node negative breast cancer patients undergoing breast conserving therapy: sentinel lymph node procedure versus follow-up

Neo-adjuvant chemotherapy followed by surgery vs. neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery vs. neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer

Influence of the intestinal microbiome on the outcome of treatment with preoperative chemoradiotherapy in patients with resectable oesophageal carcinoma

Prospective data collection initiative on colorectal cancer

The aim is to investigate the effect of the tool and training on the (numerical) precision of information about outcomes of treatment in the treatment information consultation.

National registration of patients with liver metastases treated with stereotactic body radation therapy.

Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo)Radiotherapy versus Total mesorectal excision for early Rectal Cancer?International, multi-centre, open-label, rolling phase II/III trial with a partially randomised patient preference design. Patients will choose organ preservation or standard surgery.

Study to assess the feasibility of treatment with bintrafusp alfa combined with definitive chemoradiation (carboplatin, paclitaxel and radiation) in patients with squamous cell carcinoma of the esophagus or gastroesophageal junction.

Rectal preserving treatment for early rectal cancer. A multi-centered randomised trial of radical surgery versus adjuvant radiotherapy after local excision for early rectal cancers.

Effectiveness of individual feedback and coaching on shared decision-making consultations in oncology care: A pragmatic randomized controlled trial.

Prospective cross-sectional randomised trial to study the patient’s opinion on the SDM questionnaires.

External beam radiochemotherapy and MRI based adaptive BRAchytherapy in locally advanced CErvical cancer

Randomised Phase III Trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy for women with early stage endometrial cancer

A nurse-led sexual rehabilitation programme for women with gynaecological cancers receiving radiotherapy: a randomized multicentre trial

Investigating the content, discrimination en convergence validity of the FACE-Q HNC questionaire

Evaluation of the impact of a decision aid tool for patients with advanced larynx cancer and assessment of its influence on shared decision making.

Uniform FDG-PET guided GRAdient Dose prEscription to reduce late Radiation Toxicity (UPGRADE-RT): a randomised controlled trial with dose reduction to the elective neck in head and neck squamous cell carcinoma

A phase 3 study to compare Nivolumab plus CCRT followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT followed by Nivolumab vs CCRT followed by Durvalumab in previously untreated, locally advanced non-small cell lung cancer.

Treating oligometastases with immune therapy, chemotherapy and radiotherapy, followed by definitive treatment of the primary tumour in patients with synchronous oligometastatic non small cell lung cancer.

Elderly with locally advanced Lung cancer: Deciding through geriatric Assessment  on the oPtimal Treatment strategy

In this single stage phase II trial we aim to demonstrate absolute increase in progression free survival at two years. . PFS will be determined as the time between randomization and disease progression, according to RECIST 1.1, death due to any cause or last patient contact alive and progression-free.

By getting more insight in the treatment-induced immunomodulatory effects, ultimately, in subsequent projects, this will allow to determine optimal immune stimulation and hence improved outcomes of subsequent durvalumab immune therapy. The hypothesis is that we can identify immune changes in stage III NSCLC patients receiving concurrent chemoradiation with protons or photons followed by durvalumab, as is done in standard clinical practice in The Netherlands.

A randomized trial: Durvalumab and low-dose PCI vs durvalumab and observation in radically treated patients with stage III NSCLC.

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab versus placebo following SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

Patients continue the same immune therapy they already received and get radiotherapy to one lesion. The lesion may or may not be symptomatic, but it should be a lesion that increased in size, i.e. containing resistant cells, according to RECIST 1.1 criteria. The preferred radiotherapy dose is 24 Gy in 3 fractions (dosage on the 10 Gy isodose is allowed), but other fractionation schedules (e.g. 30 Gy/ 10 fractions, 20 Gy/ 5 fractions, 20-24 Gy / 1 fraction for SRS) are allowed if these are standard for a certain location or palliative indication in the body.

The REQUITE Plus study is an extension of the original REQUITE study. The main study objective is to establish a prospective cohort of patients undergoing radiotherapy for breast, prostate or lung cancer according to local regimens and collecting standardised radiotherapy toxicity data, non-genetic risk factor data and samples for biomarker assays for the study of determinants of radiotherapy side-effects. Furthermore, the secondary objective is to establish a comprehensive centralised database and sample collection as a resource for the prospective evaluation and validation of clinical models incorporating biomarker data to identify before treatment those cancer patients who are at risk of developing long term side-effects from radiotherapy. De REQUITE Plus extension is an follow-up study to collect additional grade of toxicity data, as well as patient-reported outcome data.

Role of genomic factors on late adverse events after lymphoma.

A phase III trial of marizomib in combination with standard temozolomide-based radiochemotherapy versus standard temozolomide-based radiochemotherapy alone in patients with newly diagnosed glioblastoma.

Ependymoma in Adults, Evaluation and Treatment Protocol

Primary intracranial germ-cell tumours in adults; evaluation and treatment protocol

The hypothesis of this study is that 6 fractions of high-precision, hypofractionated radiotherapy delivered with a higher dose per fraction is non-inferior to the standard fractionation schema and is associated with better quality of life and lower costs.

Medulloblastoma in Adults Treatment Protocol, Dutch Society for Neuro-Oncology (LWNO)

Evaluation methods to assess cognitive function and predict cognitive decline after treatment of meningioma are urgently needed. In this study, patients will undergo extensive cognitive testing combined with advanced brain MRI scans.

No standard re-radiation regimen has been defined for patients with recurrent glioma. In this study we determine if re-irradiation in 4 fractions is non-inferior to 10 fractions in the primary endpoint of survival after re-irradiation.

To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)

Metastases free progression free survival in prostate cancer patients with recurrent disease (< 5 metastases) treated with radiotherapy versus radiotherapy + 6 months ADT. A multicentre, randomized study.

The aim to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose from by a hypofractionated schedule.

A randomized study between whole gland prostate brachytherapy (control arm) and hemigland prostate brachytherapy (experimental arm). The study population consists of patients with proven unilateral significant adenocarcinoma of the prostate.

Prostate cancer Immune profiling before, during and after HDR-brachytherapy in local relapsed prostate cancer.

The impact of the implementation of a decision aid tool for prostate cancer patients on the decision making process