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Nachrichten, Termine, Experten
Nachrichten, Termine, Experten
idw - Informationsdienst
Wissenschaft
Recruitment for RATIONALE will begin at the National Center of Tumor Diseases (NCT) in 2025. The study is investigating the benefits of molecularly controlled treatment for patients with rare cancers. The researchers want to prove that the progression-free survival of patients with advanced rare cancers can be doubled compared to standard therapy. For the first time, all six NCT sites are pooling their joint expertise in a study involving patients throughout Germany.
Following the official launch of the NCT and the signing of the federal-state agreement in fall 2023, the six NCT sites are now working together on innovative concepts for early clinical trials, making use of a wide range of synergies. One example is RATIONALE, a study in which researchers are focusing on rare cancers. This is the first cross-site NCT study. Following a review by the NCT study selection committee, which consists of international experts, it will involve participants from all over Germany. In terms of methodology, RATIONALE relies on comprehensive molecular analyses. This means that the researchers examine the genes and molecules of a tumour, identify pathological changes and develop personalized therapies.
The NCT is a long-term cooperation between the German Cancer Research Center (DKFZ), excellent partners in university medicine and other outstanding research partners at various locations in Germany: Berlin, Dresden, Heidelberg, SüdWest (Tübingen-Stuttgart/Ulm), WERA (Würzburg with the partners Erlangen, Regensburg and Augsburg) and West (Essen/Cologne). The aim of the NCT is to transfer innovations in cancer research in Germany quickly and in a targeted manner into studies in order to diagnose cancer according to the latest state of research and to treat it successfully while
maintaining a high quality of life. Patients are research partners on an equal footing.
This is particularly true for the RATIONALE study because patients with rare cancers have a significantly worse prognosis than those with common tumors. For example, the five-year survival rate for rare cancers is significantly lower than for common tumors (48 versus 63 percent).
Rare cancers are defined as having an incidence of no more than six per 100,000 people per year. However, all rare cancers together account for almost a quarter of all new cancer diagnoses in Europe. Those affected often receive a late or initially incorrect diagnosis and, due to a lack of commercial interest, there is a lack of meaningful clinical studies on how they could be treated effectively on an individual basis.
In order to improve the situation of patients, rare cancers are a focus of work at the NCT. The NCT pools expertise, brings in sufficient numbers of patients for clinical trials and ensures the broad participation of patients as research partners.
RATIONALE stands for “Randomized comparison of a therapy guided by comprehensive genome, epigenome and transcriptome analysis with a standard treatment in patients with advanced rare cancers”. The RATIONALE study builds on the results of the DKFZ/NCT/DKTK MASTER study. This showed that molecularly controlled treatment has the potential to significantly improve the prognosis of patients with rare tumors. Adults with advanced rare solid tumors, such as sarcomas, are included in RATIONALE. The researchers are also aiming to include the different types of cancer according to their relative frequency within the group of rare cancers. In three years, around 750 patients are to be included in RATIONALE.
Stefan Fröhling, Managing Director of the NCT Heidelberg and Head of the Department of Translational Medical Oncology at the DKFZ, is leading the RATIONALE study together with Hanno Glimm and Richard Schlenk. He says: “With RATIONALE, we want to prove that molecular control of therapy can double the progression-free survival of patients with advanced rare cancers compared to standard treatment.”
The interdisciplinary molecular tumor board, which discusses all cases, plays a key role in the RATIONALE workflow. It is made up of experts from various specialist areas from all six NCT sites. The tumor board recommends a clinical trial tailored to the patient's molecular characteristics or - if no such trial exists - an off-label treatment with drugs outside the approved indications. If necessary, reimbursement is supported within the framework of RATIONALE by centrally coordinated applications to the respective health insurers.
Hanno Glimm, Managing Director of the NCT/UCC Dresden and Head of the Department of Translational Medical Oncology at the NCT/UCC Dresden, says: “We are convinced that we will gain new research insights into rare tumors with the innovative RATIONALE study. We will be able to make a difference in the future for many patients who previously lacked treatment options for practical and economic reasons.”
Cooperation between all NCT sites is an essential prerequisite for this. Thanks to cross-site collaboration, the NCT can draw on the combined expertise of many excellent researchers in Germany. In addition, patients can be recruited more extensively and more quickly thanks to the nationwide catchment area. The NCT also achieves a short turnaround time in the preparation of information. Richard Schlenk, Head of the NCT Trial Center in Heidelberg, says: “With our interdisciplinary teams, we are able to obtain meaningful data from tissue and blood samples within four weeks and quickly recommend a tailored therapy to patients.”
Patients were closely involved in the development of RATIONALE as research partners. Through their personal expertise, they ensure that the research meets their actual needs and that they benefit from it in the best possible way. Markus Wartenberg is the spokesperson for the NCT Patient Research Council. He says: “Patients with rare cancers have so far been neglected - both in terms of research efforts and treatment options. With RATIONALE, we have designed a study with the participation of those affected that takes the patient's perspective into account and offers new perspectives.”
About the National Center for Tumor Diseases (NCT):
The National Center for Tumor Diseases (NCT) is a long-term cooperation between the German Cancer Research Center (DKFZ), excellent partners in university medical centers (UMCs) and other research institutions at various locations in Germany. The aim of the NCT is to translate innovations in cancer research in Germany into studies in a targeted and rapid manner in order to successfully diagnose and treat cancer while maintaining a high quality of life according to the latest state of research. Patients are research partners on an equal footing.
Stefan Fröhling, stefan.froehling@nct-heidelberg.de
Hanno Glimm, hanno.glimm@nct-dresden.de
Richard Schlenk, richard.schlenk@nct-heidelberg.de
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