The preparation and conducting of clinical research is a complicated, time consuming and labor intensive process, with many consecutive steps.
Maastro Trial office supports all these steps: from research idea to scientific publication.
The preparation and conducting of clinical research is a complicated, time consuming and labor intensive process, with many consecutive steps.
Maastro Trial office supports all these steps: from research idea to scientific publication.
A multicentre, open-label, phase III, parallel arms, randomised controlled trial that randomises eligible patients in a 1:1 ratio to receive induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm).
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.
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.
Thymic cancer is rare worldwide. At this time, several treatments are given for this type of tumour, like surgery, radiotherapy and chemotherapy. Radiation after an uncompleted resection of the tumour or with stage III disease is standard of care. There is not much evidence or consensus yet for radiation after surgery in patients with so called stage II tumours with regard to the efficacy. Surgery followed by radiation with protones has a good efficacy with acceptable toxicity in patients with thymic cancer, meanwhile increasing survival for these patients. In case patients receive thoracic radiation, it is important to keep the heart dose as small as possible. With protone radiation, this is possible. In this study the heart function of patients is followed and checked for a longer period after radiation.
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.