Trials Catalog

First-Line-Therapy (Metastatic Disease/Hematology)

CHONQUER

Title: CHONQUER - A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosideni in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma and IDH1 Mutation - Untreated or Previously Treated With 1 Systemic Treatment Regimen
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Stephan Richter
Registration: NCT06127407
Description: Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind,randomized, placebo-controlled study of orally administered ivosidenib. Participants arerequired to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1(IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1,2, or 3 and not eligible for curative resection. IDH1 mutant status will be determinedduring pre-screening/screening phase. Participant must have radiographicprogression/recurrence of disease according to Response Evaluation Criteria in SolidTumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in theadvanced/metastatic setting for conventional chondrosarcoma. The primary endpoint isprogression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpointsare PFS in all randomized participants, overall survival (OS) in Grades 1 and 2participants, and OS in all randomized participants.Participants who m

PM1183-C-010-22 SaLuDo

Title: Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma
Phase: phase II/III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Stephan Richter
Registration: NCT06088290
Description: The primary objective of this phase IIb/III study is to evaluate whether the combinationof lurbinectedin plus doxorubicin given as first line treatment for metastatic Leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent ReviewCommittee (IRC) when compared to doxorubicin administered as a single agent.

Second line + Treatment (Metastatic Disease)

TRABTRAP Sarkom

Title: Phase III Study Comparing Trabectedin (T) versus Trabectedin plus tTF-NGR to Entrap T inside the Tumor in Patients with Metastatic and/or Refractory Soft Tissue Sarcoma (STS; 2nd Line)
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Stephan Richter
Registration: NCT05597917
Description: In this phase III open label, controlled clinical trial patients with unresectable or metastatic soft-tissue sarcoma after failure of anthracycline-containing first line therapy or with contraindications to these drugs and CD13 positivity in central histology (grade >/= 1+) are treated to evaluate whether tTF-NGR in combination with standard trabectedin chemotherapy prolongs progression-free survival (according to iRECIST), as compared with trabectedin alone. Further objectives are to evaluate the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy with respect to the response rate and overall survival as well as to assess the safety profile of tTF-NGR combined with trabectedin. Before the randomized phase III part of the study, there was a safety run-in part. The final dose of tTF-NGR established as safe in this safety run-in part is 0.5 mg/m2 per day for 2 consecutive days following each trabectedin infusion and is used for the randomized (parallel 1:1; Arm 1: standard trabectedin, Arm 2: standard trabectedin plus tTF-NGR) phase III part of this trail. . Further dose modification for tTF-NGR is possible.

Radiotherapy Studies

EBiSaUM

Title: Pilotstudie zur Evaluierung der Bildqualität für Tumorkonturierung und Tumorvolumetrie in einem MR-Tomograph niedriger Feldstärke (EBiSaUM)
Contact: +49 351-4582238
Contact E-Mail-Address: str.studien@uniklinikum-dresden.de
Examiner: Prof. Dr. med. Dr. Esther Troost

Register and supportive Studies

SoTiSaR 2.0-NIS

Title: Register für Weichteilsarkome (engl. Soft tissue Sarcoma; STS) und andere Weichteiltumore bei Kindern, Jugendlichen und jungen Erwachsenen (Soft Tissue Sarcoma Registry 2.0-NIS) Eine nicht-interventionelle Studie für Patienten mit Rhabdomyosarkom und Nicht-Rhabdomyosarkom-artigen, Weichteilsarkomen und Tumore
Legal foundation: Berufsordnung
Contact: +49 351-4585035
Contact E-Mail-Address: Kik-dokuteam-hs65@ukdd.de
Examiner: Dr. med. Judith Lohse
Description: Prospective registration of all newly diagnosed patients (children, adolescents and young adults) with rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcomas and tumours as part of a non-interventional study/application observation (NIS) with the following objectives: 1) Data collection from patients who receive routine examinations and standard treatment in the participating centres outside of clinical studies. Off-label medications are not documented in this registry/NIS. - Collection of information on the frequency of different types of soft tissue tumours as rare diseases - Evaluation of the quality of treatment using data collection and data verification with the help of the registry and the CWS reference centres. - Prospective collection of information on epidemiological, diagnostic, molecular, clinical and treatment data from patients with WTS and other soft tissue tumours to determine whether there is a correlation between treatment outcomes and specific characteristics - Collection of survival data, including long-term follow-up, quality of life 2) Observation of the use of approved drugs WITHIN the approved indications, population (NO off-label use): - RMS treated with standard therapies (only if not included in the FaR-RMS study). No off-label use - NTRK-positive NRSTS treated with NTRK inhibitors

PTRON

Title: Primary Tumor Research and Outcome Network
Legal foundation: Berufsordnung
Examiner: Dr. med. Alexander Thomas

PRO-CTCAE

Title: Auswahl patientenrelevanter Symptome zur Entwicklung entitätsspezifischer PRO-CTCAE-Fragebögen für Patienten mit Sarkom oder GIST
Legal foundation: Berufsordnung
Examiner: Dipl. Psych. Leopold Hentschel
Description: You are currently being treated for cancer at Dresden University Hospital. In a research project, we are developing questionnaires to find out how much cancer patients are affected by the side effects of their treatment. In future, the questionnaires should help us to further develop measures for the earliest possible detection and treatment of side effects.

REGSA

Title: Deutsche Prospektive Registerstudie zur Erfassung der Behandlungspraxis von gynäkologischen Sarkomen in der klinischen Routine
Legal foundation: Berufsordnung
Contact: +49 351-4584202
Contact E-Mail-Address: studiensekretariat.gyn@ukdd.de
Examiner: Dr. med. Ulrich Canzler
Description: German prospective registry study to record the treatment practice of gynecological sarcomas in clinical routine

SAR-Reg

Title: Sarkomregister
Legal foundation: Berufsordnung
Contact: +49 351-2529
Contact E-Mail-Address: Patientenanfrage.nct-ucc@ukdd.de
Examiner: Prof. Dr. med. Jürgen Weitz
Description: Aim of the study Intensive research into biological correlations and their translation into clinical application is continuously working to improve the treatment of malignant diseases. The individual treatment options result from the combination of a detailed biological characterization of the tumour cells and a comprehensive assessment of the condition of the respective patient. You have been diagnosed with a sarcoma or there is a strong suspicion that you have a sarcoma. With this letter we invite you to participate in a research project for the systematic data collection and characterization of sarcoma diseases. The Sarcoma Registry Study is a study that aims to systematically investigate and characterize the biological and clinical aspects of sarcoma diseases. The collection and archiving of clinical data serves the purpose of medical research. Your consent to the use of associated data is voluntary. If you do not wish to participate or wish to withdraw your consent at a later date, you will not suffer any disadvantages as a result. The aim of the sarcoma study is to carry out analyses of the data and samples obtained, but also to make the samples and data obtained available to future projects researching malignant diseases. Translated with DeepL.com (free version)

Other clinical trials

GIST-Hector_GISG19 Liquid biopsy resektable GIST

Title: Nationales Biomarker-Programm für resektable gastrointestinale Stromatumoren (GIST) zur Etablierung und Validierung des Wertes der Liquid Biopsy im Spannungsfeld der klinischen Therapieentscheidungen.
Legal foundation: Berufsordnung
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Stephan Richter
Description: Cross-Platform Biomarker Program for Establishment and Validation of Liquid Biopsy for Clinical Decision Making in resectable gastrointestinal stromal tumour (GIST)

NCT MASTER

Title: Körpermaterialstudie: NCT-MASTER Platform Molecularly aided stratification for tumor eradication research
Legal foundation: Berufsordnung
Contact: +49 351-5541
Contact E-Mail-Address: master-dresden@nct-dresden.de
Examiner: Prof. Dr. med. Hanno Glimm
Description: .“Precision oncology” describes the ability to predict which patients will likely respond to specific cancer therapies based on comprehensive, high-resolution molecular diagnostics as well as the functional understanding of individual tumors. Such stratification of patients can be achieved, e.g., through next-generation sequencing of tumor DNA and RNA, revealing genomic alterations that have immediate clinical implications. DKFZ/NCT/DKTK MASTER provides a complete workflow for selection and consenting of patients, tissue processing, whole-exome/genome and RNA sequencing, bioinformatic analysis, and molecularly guided clinical decision making by molecular tumor boards, which are held three times a week and include members with expertise in clinical oncology, pathology, molecular biology, bioinformatics, and medical genetics and counseling. Since many molecular alterations identified in human cancers have unknown functional consequences and can therefore not directly be interpreted regarding their suitability as therapeutic targets, separating “driver” mutations from biologically neutral “passenger” alterations is critical for translating genetic information into the clinic. Furthermore, the therapeutic value of known oncogenic mutations may vary depending on tissue context. To address these challenges, we investigate the functional role of genetic alterations predicted to be damaging in appropriate experimental systems, followed by the analysis of phenotypic consequences. The goal of these studies is to establish a versatile platform for rapid “functionalization” of individual molecular profiles and develop a continuously evolving, “learning” system to support treatment decisions at NCT.

Trace-mIDH

Title: In-vitro-Bindungsanalyse von 18F-markiertem Ivosidenib als neuartiger PET-Tracer für IDH1-mutierte Chondrosarkome und Gliome (Trace-mIDH)
Legal foundation: Berufsordnung
Contact: +49 351-4583777
Contact E-Mail-Address: sarkome@ukdd.de
Examiner: Prof. Dr. med. Klaus-Dieter Schaser
Description: The analysis of the binding specificity of the newly developed tracer is carried out ex vivo on tumor tissue from patients with chondrosarcoma and gliomas and investigates whether the mIDH inhibitor AG-120 labeled with 18F is suitable for the specific visualization of the mutated enzyme in tissue sections. Testing on tissues with different IDH mutations allows the assessment of the binding specificity depending on the respective IDH mutation. The results allow an evaluation of the potential suitability of [18F]AG-120 for non-invasive diagnostics for the localization of an mIDH-positive tumor and potential recurrences/metastases in the patient.

HEROES-AYA

Title: Heterogeneity, Evolution, and Resistance in Oncogenic Fusion Gene-Expressing Sarcomas Affecting Adolescents and Young Adults
Legal foundation: Berufsordnung
Contact: +49 351-4585541
Contact E-Mail-Address: master-dresden@nct-dresden.de
Examiner: Dr. med. Christoph Heining
Description: HEROES-AYA will use bone and soft-tissue sarcomas caused by chimeric fusion genes as paradigmatic diseases to study the development of heterogeneity in human cancers with clonally dominant, truncal genetic drivers in multiple dimensions and translate the insights gained into new strategies for diagnostics, prognostication, prediction of treatment response and resistance, and, most importantly, therapeutic targeting of heterogeneous and continuously evolving tumors. Tumors will be subjected to novel analysis methods that allow deconvolution at single-cell and spatial resolution to capture tumor heterogeneity and evolution at multiple levels. This will be complemented by in vitro and in vivo validation of potential new vulnerabilities and the development of innovative clinical trials for well-defined patient cohorts across age groups with the clear aim of improving clinical outcomes based on the discoveries made in this project. HEROES-AYA aims to recruit 220 patients to study the following groups of disease: Ewing sarcoma, Alveolar rhabdomyosarcoma, Desmoplastic small round cell tumor, Alveolar soft part sarcoma, Synovial sarcoma, Inflammatory myofibroblastic tumor, NTRK-rearranged sarcomas, BCOR-rearranged sarcomas, CIC-rearranged sarcomas, Solitary fibrous tumor, Myxoid liposarcoma, Epithelioid hemangioendothelioma.

iEuroEwing

Title: INTERNATIONAL EURO EWING TRIAL FOR TREATMENT OPTIMISATION IN PATIENTS WITH EWING SARCOMA
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Stephan Richter
EudraCT-number: 2019-004153-93
Description: The primary aim and rationale of this protocol are to improve the survival of patients with Ewing sarcoma. iEuroEwing is an overarching protocol with two randomised comparisons addressing therapeutic questions. The primary aim of the iEuroEwing-SR part is to improve EFS by introducing a maintenance treatment with known efficacy in patients with Ewing sarcoma and other small blue round cells sarcomas in a randomised design.

Das Überleben bei Sarkomen verstehen (PROSa+)

Title: Das Überleben bei Sarkomen verstehen: Risikoprofile, Befinden und unerfüllte Bedarfe – Ein Projekt von Forschenden, Sarkomzentren und Patienten-Expert:innen (PROSa+)
Legal foundation: Berufsordnung
Contact: +49 351-45819057
Contact E-Mail-Address: martin.eichler@ukdd.de
Examiner: Dr. Martin Eichler

NCT MASTERsg Panelsequenzierung

Title: NCT MASTERsg Panelsequenzierung
Legal foundation: Berufsordnung
Contact: +49 351-4585541
Contact E-Mail-Address: master-dresden@nct-dresden.de
Examiner: Prof. Dr. med. Hanno Glimm
Description: The MASTERsg ("subgenomic") program offers, just like the NCT MASTER Program, a comprehensive molecular characterization of our patient's tumors. Using a next generation sequencing-based gene panel, 290 Cancer relevant genes are analyzed and additional information about microsatellite-instability, gene fusions and copy number variations are obtained.