Condition: Rare Cancer · Sponsor: German Cancer Research Center
Rare cancers, defined by an incidence of fewer than 6 cases per 100,000 persons per year, constitute nearly 25% of adult malignancies. They are associated with poor patient outcomes due to incomplete biological understanding and inadequate representation in clinical trials. To address this gap, the DKFZ/NCT/DKTK MASTER (Molecularly Aided Stratification for Tumor Eradication Research) program, developed by NCT and DKFZ, integrates whole-genome/exome sequencing (WGS/WES), RNA sequencing (RNA-seq), and genome-wide DNA methylation profiling to inform clinical decision-making in patients with advanced rare cancers. This approach has demonstrated significant improvements in overall response rates (ORR) in 24% and disease control rates (DCR) in 55% of cases, with a progression-free survival (PFS) ratio greater than 1.3 in 36% of patients. The randomized, multi-basket, phase II, Italian multicenter ROME study conducted among pretreated patients with metastatic cancer, demonstrated that targeted therapy guided by comprehensive genomic profiling and molecular tumor board (MTB) recommendations significantly improved overall response rate and progression-free survival. Additionally, the study revealed a substantial long-term PFS benefit extending to 12 months and beyond. Although the toxicity profiles differed between the targeted therapy and standard-of-care groups, the incidence of adverse events was comparable. These findings, reported at the ESMO Congress 2024, emphasize the pivotal…
This description comes directly from the study's public registry record.
Trial Management and Support, NCT Heidelberg Clinical Trial Center · 49 6221 566553 · rationale_pm@nct-heidelberg.de
Always discuss trial participation with your own doctor first.
| Universitätsklinikum Augsburg | Augsburg, Germany | Recruiting |
| Charité Berlin | Berlin, Germany | Recruiting |
| Universitäts-Klinikum Köln | Cologne, Germany | Recruiting |
| Medizinische Fakultät der TU Dresden | Dresden, Germany | Recruiting |
| Uniklinikum Erlangen | Erlangen, Germany | Recruiting |
| Universitätsmedizin Essen | Essen, Germany | Recruiting |
| Universitätsklinikum Freiburg, Tumorzentrum Freiburg - CCCF | Freiburg im Breisgau, Germany | Not Yet Recruiting |
| Universitätsklinikum Hamburg-Eppendorf (UKE) | Hamburg, Germany | Not Yet Recruiting |
| Universitätsklinikum Heidelberg | Heidelberg, Germany | Recruiting |
| Universitätsmedizin der Johannes Gutenberg- Universität Mainz | Mainz, Germany | Not Yet Recruiting |
| Comprehensive Cancer Center , LMU München | München, Germany | Not Yet Recruiting |
| Comprehensive Cancer Center Ostbayern (CCCO) Universitätsklinikum Regensburg, | Regensburg, Germany | Recruiting |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06855134