Patient-reported Outcome Research
In order to better consider the needs of patients in cancer therapy, we are responsible for the area of patient-reported outcomes (‘the success of therapy as documented by the patients themselves’) and quality of life in numerous randomised clinical trials and registry studies dealing with the improvement of cancer therapy.
The aim is to incorporate these previously under-researched aspects holistically into treatment decisions, both within the individual studies and in overarching research.
Ongoing (recruiting) studies/projects
The RATIONALE study is a research project focused on personalized treatment for rare cancers. It investigates whether molecularly guided therapy, based on comprehensive genomic analysis, is more effective than standard therapy. The study focuses on advanced-stage tumors (e.g., sarcomas) to identify tailored treatment approaches.
All six NCT sites are participating in the study: Heidelberg, Dresden, Berlin, Southwest (Tübingen-Stuttgart/Ulm), WERA (Würzburg with partners in Erlangen, Regensburg, and Augsburg), and West (Essen/Cologne).
NCT Press Releases: Rationale Focuses on Rare Cancers: First Cross-Site Study by the NCT
Pasireotide as Maintenance Treatment with monthly deep intramuscular injection in SSTR2/3/5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor.
In cooperation with Prof. Dr. Richard Schlenk, National Centrum for Tumor Diseases (NCT), Heidelberg
For actual information please look here
Clinical study
COGNITION-GUIDE Phase II-Study
Within the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver molecularly-tailored cancer care by implementing an additional response- and genomics-guided post-neoadjuvant therapy after finishing the guideline-compliant post-neoadjuvant treatment in high-risk breast cancer patients with residual cancer burden after neoadjuvant therapy to reduce the substantial risk of local and distant relapse.
In cooperation with Prof. A. Schneeweiss and Prof. R. Schlenk, National Center for Tumor Diseases (NCT), Heidelberg
Register study
„A prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Patients with Myeloid Neoplasms"
The Myeloid Neoplasms Biology and Outcome Project
In cooperation with Prof. Dr. Richard Schlenk, National Center for Tumor Diseases (NCT), Heidelberg
Register study
"A prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Patients with Soft-tissue and Bone Sarcoma"
A prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Patients with Soft-tissue and Bone Sarcoma.
In cooperation with Prof. Dr. Richard Schlenk, National Center for Tumor Diseases (NCT), Heidelberg
Studies with completed recruitment and ongoing research
Clinical study
TROPHIT1: A Randomized, Open Label, Multicenter Phase II/III Trial of Sacituzumab Govitecan Compared to Standard of Care in Metastatic, Refractory Colorectal Cancer Patients.
In cooperation with PD Dr. med. Bruno Christian Köhler, National Center for Tumor Diseases (NCT), Heidelberg.
Publication
2025 - European journal of cancer
"TROPHIT1—a randomized, open-label, multicenter, phase II/III trial of sacituzumab govitecan compared to standard of care in metastatic colorectal cancer patients" B.C. Köhler, G.M. Haag, L. Le Cornet, et al. https://doi.org/10.1016/j.esmogo.2024.100118
Clinical study
CRAFT
Continuous Reassessment with Flexible Extension in Rare Malignancies Study, Treatment stratification of younger adults with advanced-stage cancers and patients with rare tumors based on whole-genome sequencing, transcriptome sequencing, and DNA methylation analysis.
In cooperation with Prof. R. Schlenk, National Center for Tumor Diseases (NCT), Heidelberg
Publication
Heilig CE, Horak P, Kreutzfeldt S, Teleanu V, Mock A, Renner M, Bhatti IA, Hutter B, Hullein J, Frohlich M, Uhrig S, Susse H, Heiligenthal L, Ochsenreither S, Illert AL, Vogel A, Desuki A, Heinemann V, Heidegger S, Bitzer M, Scheytt M, Brors B, Hubschmann D, Baretton G, Stenzinger A, Steindorf K, Benner A, Jager D, Heining C, Glimm H, Frohling S, Schlenk RF. Rationale and design of the CRAFT (Continuous ReAssessment with Flexible ExTension in Rare Malignancies) multicenter phase II trial. ESMO Open. 2021 Dec;6(6):100310. doi: 10.1016/j.esmoop.2021.100310. Epub 2021 Nov 20.
IntenSify
An open-label Phase I Trial of the CYP3A Inhibitor Cobicistat and the cytostatics Gemcitabine and nab-Paclitaxel in Patients with Advanced Stage or metastatic Pancreatic Ductal Adenocarcinoma to evaluate the combination's Pharmacokinetics, Safety and Efficacy.
In cooportaion with PD Dr. N. Hohmann, National Center for Tumor Diseases (NCT), Heidelberg
Publication
Hohmann N, Sprick MR, Pohl M, Ahmed A, Burhenne J, Kirchner M, Le Cornet L, Kratzmann M, Hajda J, Stenzinger A, Steindorf K, Delorme S, Schlemmer HP, Riethdorf S, van Schaik R, Pantel K, Siveke J, Seufferlein T, Jager D, Haefeli WE, Trumpp A, Springfeld C. Protocol of the IntenSify-Trial: An open-label phase I trial of the CYP3A inhibitor cobicistat and the cytostatics gemcitabine and nab-paclitaxel in patients with advanced stage or metastatic pancreatic ductal adenocarcinoma to evaluate the combination's pharmacokinetics, safety, and efficacy. Clin Transl Sci. 2023 Dec;16(12):2483-2493. doi: 10.1111/cts.13661. Epub 2023 Nov 3.
GnG "Randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare intensive postremission therapy double blinded with or without glasdegib in older patients with newly diagnosed AML"
The study is a randomized phase III trial with a 2x2 factorial design with measurable residual disease and event-free survival as primary endpoints, respectively.
In cooperation with Prof. Dr. Richard Schlenk, National Center for Tumor Diseases (NCT), Heidelberg and the Medical University of Heidelberg
Publication
Jaramillo S, Krisam J, Le Cornet L, Kratzmann M, Baumann L, Sauer T, Crysandt M, Rank A, Behringer D, Teichmann L, Gorner M, Trappe RU, Rollig C, Krause S, Hanoun M, Hopfer O, Held G, Buske S, Fransecky L, Kayser S, Schliemann C, Schaefer-Eckart K, Al-Fareh Y, Schubert J, Geer T, Kaufmann M, Brecht A, Niemann D, Kieser M, Bornhauser M, Platzbecker U, Serve H, Baldus CD, Muller-Tidow C, Schlenk RF. Rationale and design of the 2 by 2 factorial design GnG-trial: a randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare double-blinded intensive postremission therapy with or without glasdegib in older patients with newly diagnosed AML. Trials. 2021 Nov 3;22(1):765. doi: 10.1186/s13063-021-05703-w.
Q-HAM “Quizartinib and High-dose Ara-C plus Mitoxantrone in Relapsed/Refractory AML with FLT3-ITD”
Phase II clinical trial.
In cooperation with Prof. Dr. Richard Schlenk, National Center for Tumor Diseases (NCT), Heidelberg and the Medical University of Heidelberg
Publication
Jaramillo S, Le Cornet L, Kratzmann M, Krisam J, Gorner M, Hanel M, Rollig C, Wass M, Scholl S, Ringhoffer M, Reichart A, Steffen B, Kayser S, Mikesch JH, Schaefer-Eckart K, Schubert J, Geer T, Martin S, Kieser M, Sauer T, Kriegsmann K, Hundemer M, Serve H, Bornhauser M, Muller-Tidow C, Schlenk RF. Q-HAM: a multicenter upfront randomized phase II trial of quizartinib and high-dose Ara-C plus mitoxantrone in relapsed/refractory AML with FLT3-ITD. Trials. 2023 Sep 15;24(1):591. doi: 10.1186/s13063-023-07421-x.
