Klinische Studien spielen bei der Entwicklung und Verbesserung von neuen Therapien eine wichtige Rolle. Für viele Patient*innen ermöglicht die Teilnahme an einer Klinischen Studie auch den Zugang zu innovativen Medikamenten.

Jedes Jahr werden im CIO Aachen Bonn Köln Düsseldorf rund 400 Klinischen Studien zu onkologischen Themen durchgeführt.

Studienregister CIO Bonn

176 Einträge gefunden

Erleben psychogener, nichtepileptischer Anfälle im Behandlungsverlauf

ISRCTN | NCT
Erleben psychogener, nichtepileptischer Anfälle im Behandlungsverlauf
aktiv
Studienzentrum: Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinisches Studienzentrum Psychiatrie und Psychotherapie
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Primäres Studienziel
Die Patient*innen werden nach Diagnosestellung anhand eines selbst erstellten Interviewleitfadens (Protokollbogen zum Erleben psychogener, nicht-epileptischer Anfälle im Behandlungsverlauf, PEB) nach ihrem subjektiven Erleben vor, während und nach psychogenen, nichtepileptischen Anfällen offen befragt. Im Anschluss erfolgt eine Nachfrage im Hinblick auf aufdrängende Erinnerungen, dissoziative Symptome, Emotionen, Kognitionen/Gedanken und Körperwahrnehmungen. Weitere Fragen betreffen die aktuelle Anfallsfrequenz, wahrgenommene Anfallsauslöser, außerhalb von Anfällen auftretende aufdrängende Erinnerungen und Alpträume, das bestehende Krankheitsverständnis, die Akzeptanz der Diagnose und das Vorliegen einer aktuellen oder vergangenen psychiatrischen/psychosomatischen bzw. psychotherapeutischen Behandlung. Zu weiteren Zeitpunkten (nach 3, 6 und 12 Monaten) werden die Patient*innen erneut nach ihrem subjektiven Anfallserleben befragt. Zusätzlich erfolgen detaillierte Fragen zu seit Diagnosestellung eingenommenen Medikamenten und durchgeführten Therapien. Die Fragen beziehen sich auf Umfang und Modalität (ambulant/stationär/teilstationär), sowie auf die inhaltliche Ausrichtung (z.B. Verhaltenstherapie / Tiefenpsychotherapie) und eingesetzte Techniken (z.b. Trauma-Exposition) der Therapien. Sollten in den Therapien aufdrängende Erinnerungen traumatischer Lebensereignisse behandelt worden sein wird zudem kategoriell gefragt, welche Art von Traumatisierungen aufgetreten sind und wie oft es derzeit noch zu entsprechenden intrusiven Erinnerungen bzw. Alpträumen kommt.
Sekundäre Studienziele
Zu den angegebenen Zeitpunkten (T0, T1, T2, T3) wird der diagnostische Status und Schweregrad einer posttraumatischen Belastungsstörung festgestellt. Hierzu wird die "Life-Events Checklist for DSM-5" (LEC-5, deutsche Version) sowie die "Posttraumatic Stress Disorder Checklist" (PCL-5, deutsche Version) oder die "Clinician Administered PTSD Scale for DSM-5" (CAPS-Interview, deutsche Version) angewandt. Zudem wird das "State-Trait Anger Expression Inventory-2" (STAXI-2, deutsche Version), das "Affective Style Questionnaire" (ASQ, deutsche Version) und das "State-Trait Anxiety Inventory" (STAI, deutsche Version) angewandt. Hierdurch werden Ärgerausdruck, Emotionsregulation und Angsterleben festgehalten. In einem weiteren Schritt sollen genetische Besonderheiten der Population ermittelt werden, weshalb eine Blutentnahme und eine genetische bzw. epigenetische Analyse erfolgt.
Einschlusskriterien
Geschlecht: Alle Mindestalter: 18 Jahre Höchstalter: 65 Jahre Patienten mit Diagnosen aus dem Bereich der neurotischen, Belastungs- und somatoformen Störungen (ICD-10 F40-F48), der Persönlichkeits- und Verhaltensstörungen (ICD-10 F60-F69) und/oder der Verhaltens- und emotionalen Störungen mit Beginn in der Kindheit und Jugend (ICD-10 F90-F98). Vorheriger Nachweis der entsprechenden Erkrankung durch eine Video-EEG-Untersuchung (ggf. als Ausschlussdiagnose).
Ausschlusskriterien
Fehlende Einwilligungsfähigkeit, akute Suizidalität, stattgehabte Hirnoperation. Bestimmte infektiöse und parasitäre Krankheiten (ICD-10 A00-B99), bösartige Tumorerkrankungen (ICD-10 C00-C97), organische psychische Störungen (ICD-10 F00-F09), Psychische und Verhaltensstörungen durch psychotrope Substanzen (ICD-10 F10-F19), Schizophrenie, schizotypie und wahnhafte Störungen (ICD-10 F20-F29), Intelligenzstörungen (ICD-10 F70-F79), Entwicklungsstörungen (ICD-10 F80-F89), Systematrophien, die vorwiegend das Zentralnervensystem betreffen (ICD-10 G10-G14), Sonstige degenerative Erkrankungen des Nervensystems (ICD-10 G30-G32), zerebrovaskuläre Krankheiten (ICD-10 I60-I69), Schwangerschaft, Geburt und Wochenbett (ICD-10 ICD-10 O00-O99).

NPC-Nivo

ISRCTN | NCT NCT06019130
Nivolumab in Kombination mit Cisplatin und 5-Fluorouracil als Induktionstherapie bei Kindern, Jugendlichen und jungen Erwachsenen mit EBV-assoziiertem Nasopharynxkarzinom
aktiv
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Bösartige Neubildung des Nasopharynx
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Phase II
Studienzentrum: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Klinisches Studienzentrum Hämatologie und Onkologie
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Diagnose (ICD-10-GM): C11
Diagnose: Bösartige Neubildung des Nasopharynx
Alter: ab 6 bis 65
Primäres Studienziel
To increase the percentage of NPC patients with complete response (CR) on magnetic resonance imaging (MRI) and PET-(CT or MRI) after induction chemotherapy, thereby allowing to reduce the dosage of radiotherapy from 59.4 Gy to 54 Gy in in children, adolescents and young adults ≤ 25 years with locoregional disease
Sekundäre Studienziele
To investigate the safety of Nivolumab in combination with standard induction chemotherapy in children and adults with nasopharyngeal carcinoma To investigate the safety of Nivolumab in combination with radiochemotherapy in children and adults with nasopharyngeal carcinoma not responding to induction therapy or with metastases Event-free and overall survival of patients
Einschlusskriterien
Auswahl: 1. Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents, aged between 3 years and 17 years, OR histologically confirmed new diagnosis of EBV-positive nasopharyngeal carcinoma, WHO stage II or III, in subjects ≥ 18 years 2. Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients > 25 years of age (AJCC, 8th edition) 3. Measurable disease by MRI per RECIST 1.1 criteria
Ausschlusskriterien
Auswahl: 1. Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients > 25 years of age 2. Recurrent nasopharyngeal carcinoma 3. Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy 4. Prior chemotherapy and/or radiotherapy

vTB+

ISRCTN | NCT
Wirksamkeitsprüfung des Video-Tumorboards PLUS (vTB+) im Rahmen des Verbundprojekts ONCOnnect
aktiv
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Bösartiges Melanom der Haut
Studienzentrum: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Klinisches Studienzentrum für Integrierte Onkologie
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Diagnose (ICD-10-GM): C43
Diagnose: Bösartiges Melanom der Haut
Alter: ab 18
Primäres Studienziel
Steigerung des Anteils externer Patient:innen im Video- Tumorboard (um 5 %)
Sekundäre Studienziele
Steigerung des Anteils an externen Patient:innen in Studien (um 5 %) Anteil der umgesetzten TB-Beschlüsse an allen Vorstellungen (für externe Patient:innen) (mind. 75 %) Anteil der externen Patient:innen, denen nach Vorstellung im vTB+ mindestens ein Supportivangebot unterbreitet wird (mind. 10 %) Dauer der Beschlussübermittlung nach TB-Vorstellung (max. 5 Werktage) Zeit zwischen ärztlicher Anordnung bis Umsetzung SAPV- Anbindung (max. 5 Werktage) Zeit zwischen ärztlicher Empfehlung für Palliativdienst (z.B. über vTB+) an die externen Mitbehandelnden (Hausärzt:in) und Erstkontakt (ohne Zielwert)
Einschlusskriterien
Die Patient:innen müssen mind. 18 Jahre alt sein, ihre Zustimmung zur Studie (Patienteneinwilligung) erteilt haben und gem. der gemeinsamen Definition als extern gelten. Sie sollen lt. externer Ärtz:in aufgrund der Erkrankung/Diagnose im vTB+ vorgestellt werden. Die externen Ärzt:innen müssen im Rahmen des Projekts ärztliche Zulassung besitzen und Patient:innen behandeln die infrage kommen, im vTB+ vorgestellt zu werden.
Ausschlusskriterien
Sprachliche oder sonstige Einschränkungen (wie z.B. Demenz), die die eigenständige Zustimmung zur Datenschutzerklärung verhindern. Keine Zustimmung zur Studienteilnahme oder Rücknahme der Zustimmung im Studienverlauf. Zudem werden externe Ärzt:innen von der Studie ausgeschlossen, wenn keine gemeinsame Kooperationsvereinbarung ausgehandelt und unterzeichnet werden kann.

INCA34176-357

EudraCT 2023‑510292‑65‑00 | NCT NCT06585774
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
aktiv
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Leukämie
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Phase III
Studienzentrum: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Klinisches Studienzentrum Hämatologie und Onkologie
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Diagnose (ICD-10-GM): C90-C95
Diagnose: Leukämie
Alter: ab 18
Primäres Studienziel
To compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe cGVHD
Sekundäre Studienziele
TTo evaluate the clinical benefit of axatilimab in combination with corticosteroids in participants with cGVHD.
Einschlusskriterien
Auswahl: Moderate cGVHD: At least 1 organ (except lung) with a score of 2, ≥ 3 organs involved with a score of 1 in each organ, or lung score of 1. OR Severe cGVHD: At least 1 organ with a score of 3, or lung score of 2 or 3 Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry KPS score ≥ 60%
Ausschlusskriterien
Auswahl: Received more than 1 prior allo-HCT. Prior autologous HCT is allowed Has overlap cGVHD, defined as the presence of features or characteristics of aGVHD with simultaneous diagnostic and/or distinctive features of cGVHD. Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD Received previous systemic treatment for cGVHD, including extracorporeal photopheresis

EORTC 2427-BTG

ISRCTN | NCT NCT06809322
VIGOR Vorasidenib as maintenance treatment after first-line chemoradiotherapy in IDH-mutant grade 2 or 3 astrocytoma: a placebo-controlled, triple-blind, randomized phase III study
aktiv
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Phase III
Studienzentrum: Universitätsklinikum Bonn, Zentrum für Neuroonkologie, Klinisches Studienzentrum Neuroonkologie
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Primäres Studienziel
In this phase III study, the main goal is to demonstrate that vorasidenib maintenance therapy improves locally assessed progression-free survival (PFS) from enrolment compared to placebo in patients with IDH-mutant, CNS5 WHO grade 2 or 3 astrocytoma following the completion of firstline chemoradiotherapy.
Sekundäre Studienziele
• To investigate the effect of vorasidenib versus placebo on centrally assessed PFS from enrolment. • To evaluate PFS from the start of radiotherapy in participants receiving vorasidenib compared to placebo. • To assess the impact of vorasidenib maintenance therapy on overall survival (OS) compared to placebo. • To determine the response rate of vorasidenib maintenance therapy versus placebo.
Einschlusskriterien
Before patient's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations. • Age ≥ 18 years EORTC-2427-BTG Vorasidenib maintenance for IDH mutant astrocytoma Version 1.0 31 March 19, 2025 • Integrated diagnosis of astrocytoma, IDH-mutant, CNS5 WHO grade 2 or 3, per local assessment, with documented IDH1 or IDH2 mutation based on local testing of tumour tissue (IDH1 R132H/C/G/S/L or IDH2 R172K/M/W/S/G) • At least 1 prior surgery for glioma (biopsy, partial resection, gross-total resection) • Completed first-line standard of care radiotherapy (minimum 50.4 Gy, photons or protons allowed) followed by completed SoC adjuvant chemotherapy (i.e., either 4-12 cycles of temozolomide or 2-6 cycles of PCV). Note: Dose reductions or chemotherapy adaptations (including the omission of PCV components) for toxicity in any cycles are allowed. • Last chemotherapy dose of first line chemoradiotherapy more than 6 weeks and less than 12 weeks before enrolment. • Recovered from any clinically relevant toxicity of the previous chemoradiotherapy unless stable and manageable per investigator´s judgement. • Adequate bone marrow function: absolute neutrophil counts (ANC) ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets ≥ 100 x 109/L. • Adequate renal function: serum creatinine ≤ 2.0 x ULN, or creatine clearance > 40 mL/min, as calculated based on CKD-EPI 2021 formula (see Appendix J). • Adequate hepatic function: • Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin ≥1.5 × ULN) • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at or below ULN. • Alkaline phosphatase (ALP) ≤ 2.5 x ULN. • WHO performance status 0-2 • Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrolment. • Baseline contrast-enhanced cranial MRI available. • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within two weeks prior to enrolment; a serum or urine pregnancy test must be conducted and confirmed negative within 72 hours prior to the first dose of study treatment.
Ausschlusskriterien
• Presence of 1p19q co-deletion, per local assessment. • Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment. • Prior therapy with an IDH inhibitor or IDH vaccine. • Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. • Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4 • Significant known active cardiac disease within 6 months before enrolment, including New York Heart Association Class III or IV congestive heart failure (Appendix I), myocardial infarction, unstable angina, and/or stroke. • Known hypersensitivity to any of the components of vorasidenib. • Ongoing use of medications that are CYP2C8, CYP2C9, CYP2C19, or CYP3A substrates with a narrow therapeutic index (see Appendix R). Note: Participants must be transferred to other medications before receiving the first dose of study drug. • Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted. • Known active inflammatory gastrointestinal disease, chronic diarrhoea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the gastrointestinal absorption of drugs administered orally. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential). • Inability or known contraindication to undergo contrast media MRI. • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the in the trial.

NeuroPRO

ISRCTN | NCT
Evaluation der Übereinstimmung zwischen ärztlichen und patientenbasierten Toxizitätserhebung bei Hirnbestrahlungen
aktiv
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Glioblastom
Studienzentrum: Universitätsklinikum Bonn, Klinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum Strahlentherapie Radioonkologie
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Diagnose (ICD-10-GM): C71 - Glioblastom
Diagnose: Glioblastom
Alter: ab 18
Primäres Studienziel
Ziel dieser Studie ist es, mögliche Diskrepanzen zwischen CRO und PRO bei Bestrahlung bösartiger zerebraler Raumforderungen zu evaluieren. Dazu werden validierte Fragebögen durch Patient*innen und Ärzt*innen zu drei verschiedenen Zeitpunkten ausgefüllt: vor der ersten Bestrahlung, nach der letzten Bestrahlung sowie bei der regulären strahlentherapeutischen Nachsorge (ca. 6 Wochen nach Abschluss der Behandlung). Um Diskrepanzen zu evaluieren werden folgende statistische Parameter ausgewertet: ordinale logistische Regressionsanalyse, C-Statistik (concordance index) und Cohen's Kappa.
Einschlusskriterien
Einschlusskriterien: (1) Alter: mindestens 18 Jahre, (2) Bildgebender Verdacht auf eine bösartige zerebrale Neubildung mit Indikation zur Strahlentherapie, (3) ECOG max. 2 und (4) Informierte Einwilligung.
Ausschlusskriterien
Ausschlusskriterien: (1) Eingeschränkte Urteilsfähigkeit und (2) Nicht deutschsprachig.

ACTICCA-2

NCT 06175845
Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2 trial)
aktiv
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Intrahepatisches Gallengangskarzinom | Bösartige Neubildung sonstiger und nicht näher bezeichneter Teile der Gallenwege
Studienzentrum: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Onkologische Gastroenterologie
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Diagnose (ICD-10-GM): C22.1, C24
Diagnose: Intrahepatisches Gallengangskarzinom | Bösartige Neubildung sonstiger und nicht näher bezeichneter Teile der Gallenwege
Alter: ab 18
Primäres Studienziel
The primary endpoint is time-to-first event (during 6 months follow up), i.e. stent dysfunction defined by bilirubin >5 mg/dl and/or cholangitis (fever >38.5°C and/or increase in C-reactive protein by at least 3-fold upper limit of normal and at least 20% from baseline without extrahepatic focus and absence of tumor progression) leading to premature stent replacement and/or disruption of chemotherapy (all possible events will be reviewed by a blinded and independent ERC.)
Sekundäre Studienziele
The secondary endpoints will include:  QoL  Clinical event rate @ 6 months  OS  Total days of over-night-hospital-stays during the trial period  Safety (terminology and grading according to NCI CTCAE v5)
Einschlusskriterien
1. Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT) 2. Written informed consent 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Age ≥18 years 5. Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT 6. No prior radiofrequency ablation (RFA) for CCA 7. No repeated bile duct stenting in the past 3 months (trial inclusion is possible upon first stent replacement or initial stent placement within past 3 months) 8. No concomitant disease or malignancy interfering with the study procedure or efficacy outcome measures, particularly no severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction within ≤3 months, significant arrhythmias) and no psychiatric disorders precluding understanding of information of trial related topics and giving informed consent
Ausschlusskriterien
Inclusion and exclusion criteria are based on the main selection criteria for patients with unresectable perihilar and/or ductal CCA who are recommended to receive bile duct stenting and palliative systemic therapy by current guidelines

adIVO

EudraCT 2024-520219-42-00
A phase II trial of ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma
aktiv
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Intrahepatisches Gallengangskarzinom
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Phase II
Studienzentrum: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Onkologische Gastroenterologie
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Diagnose (ICD-10-GM): C22.1
Diagnose: Intrahepatisches Gallengangskarzinom
Alter: ab 18
Primäres Studienziel
To assess the efficacy of ivosidenib maintenance directly after adjuvant SOC chemotherapy in curativ mlDH1 CCA
Sekundäre Studienziele
To evaluate further efficacy as well as to assess safety and impact of the quality of life of ivosidenib maintenance directly after adjuvant SOC chemotherapy in curativ mlDH1 CCA
Einschlusskriterien
1. Patient* provides signed informed consent. 2. Patient is ≥ 18 years at the time of given informed consent. 3. Patient has histologically documented curatively resected intrahepatic cholangiocarcinoma, without metastatic spread, in the adjuvant situation (R0-resected) 4. Patient has proven IDH1 mutation (IDH1-variant status evaluated locally by certified test on formalin-fixed paraffin-embedded tumor tissue specimen. If local testing for screening is not possible per local standard, tumor tissue samples will be subject to pre-screening via central IDH1 pyrosequencing) 5. Patient finished adjuvant systemic SOC chemotherapy (with regimens allowed per the protocol) directly prior to trial inclusion. 6. Radiologic imaging available that shows that patient is tumor free at the timepoint of enrollment (not older than 6 weeks from the day of inclusion). 7. Patient has ECOG Performance status ≤ 1 8. Hematological, hepatic and renal function parameters adequate to allow targeted therapy with ivosidenib at investigator´s discretion and IB. 9. Patient has adequate coagulability to allow targeted therapy with ivosidenib at investigator´s discretion and IB. Patients receiving warfarin / Phenprocoumon must be switched to low molecular weight heparin and before starting trial-specific. 10. Patient must be willingly to provide liquid biopsy samples, archival tumor tissue samples (if available), and in the event of disease recurrence, re-biopsy samples (if re-biopsy is considered safe for the patient) for the translational research program. 11. Female patients of childbearing potential or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of trial treatment. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy (see section 5.2.6 for more information). 12. Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the trial including undergoing treatment and scheduled visits and examinations including follow up. *There is no data that indicates a specific gender distribution. Therefore, patients are included regardless of their gender.
Ausschlusskriterien
1. Patient has a metastatic or R+ resected biliary tract cancer. 2. Patient received previous therapy with an IDH1 inhibitor. 3. Patient has known presence of tumors other than intrahepatic cholangiocarcinoma or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years. 4. Simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone therapy not described in the trial protocol. 5. Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative radiotherapy only for symptom control). 6. Patient has a stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis. 7. Patient has known allergic / hypersensitive reactions to at least one of the treatment components. 8. Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the trial. 9. Patient has a known presence of an active, uncontrollable infection. 10. Patient has QTc > 480ms or other factors that, in the discretion of the investigator increase significantly the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT syndrome). NOTE: Medications that prolong the QT interval should be avoided, unless they can be transferred to other medication within ≥ 5 half-lives to dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTc should be closely monitored). 11. Patient has active disseminated intravascular coagulation. 12. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 13. Patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug. 14. Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect. NOTE: strong CYP3A4 inducers or sensitive CYP3A4 substrates with narrow therapeutic window should be avoided, unless they can be transferred to alternative medication within at least 5-half lives prior to dosing. 15. Female patient is pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment. 16. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.

TRITICC2

EudraCT 2024-517330-18
Efficacy and safety of trifluridin/tipiracil in combination with nanoliposomal irinotecan as a second line therapy in patients with cholangiocarcinoma
aktiv
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Bösartige Neubildung der Leber und der intrahepatischen Gallengänge
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Phase III
Studienzentrum: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Onkologische Gastroenterologie
Weitere Informationen anzeigen
Diagnose (ICD-10-GM): C22
Diagnose: Bösartige Neubildung der Leber und der intrahepatischen Gallengänge
Alter: ab 18
Primäres Studienziel
Median progression free survival (PFS) assessed by the local investigator at each site (time from first administration of chemotherapy to the date of radiological or clinical tumor progression or death of any cause whichever comes first).
Sekundäre Studienziele
Efficacy: • Progression-free survival rate @ 4 months defined as the proportion of patients with non-progressive disease 4 months after inclusion • Median overall survival (time interval from first administration of chemotherapy to date of death from any cause) • Proportion of patients with an objective response according to RECIST 1.1 Response and progression will be assessed by the local investigator. Safety: • Type, frequency and severity of adverse events according to NCI CTCAE version 5.0 specifying seriousness and expectedness according to IB (AE, SAE, SUSAR) Health-Related Quality of Life: • HR QoL according to EORTC QLQ C30 and the EQ-5D-5L
Einschlusskriterien
Subjects, fulfilling the following inclusion criteria are suitable for participation in the study: 1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥18 years at time of study entry 3. Histologically or cytologically confirmed, non-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma 4. Measurable or assessable disease according to RECIST 1.1 5. Documented disease progression after prior gemcitabine or gemcitabine containing therapy or intolerance to such a treatment. Examples of permitted therapies include, but are not limited to: a) Single agent gemcitabine); b) Any gemcitabine-based regimen, with or without maintenance gemcitabine 6. ECOG performance status 0-1 7. Ability to take medications orally 8. Adequate blood count, liver-enzymes, and renal function as follows: ANC ≥ 1,500 cells/μL and Platelet count of ≥ 100 x 109/L (≥100,000 per mm3) and Hemoglobin ≥ 8 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL) Serum total bilirubin of ≤ 1.5x upper normal limit (ULN) (biliary drainage is allowed for biliary obstruction; elevated bilirubin should be caused by obstruction not impaired liver function as assessed by albumin and INR values): Albumin levels ≥ 2.8 g/dL Patients not receiving therapeutic anticoagulation must have an INR< 1.5 ULN and PTT < 1.5 ULN within 7 days prior to inclusion. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion. AST (SGOT) and ALT (SGPT) ≤ 5 x institutional upper limit of normal Serum Creatinine ≤ 1.5 x ULN and a calculated glomerular filtration rate ≥ 30 mL per minute Adequate renal and bone marrow function 9. Women of childbearing potential6 must have a negative pregnancy test and must agree to adequate birth control. Males must agree to adequate birth control
Ausschlusskriterien
Exclusion Criteria Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study: 1. Age < 18 years 2. CNS metastases 3. Active, uncontrolled infection 4. Additional malignancy within the past 2 years (except adequately treated in-situ carcinoma of the cervix or non-melanoma skin cancer) 5. Clinically significant gastrointestinal disorders including bleeding, inflammation, occlusion, or diarrhea > grade 1 6. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results 7. Known hypersensitivity to trifluridin/tipiracil or Nal-IRI or their components 8. Medication that is known to interfere with any of the agents applied in the trial 9. Pregnant or lactating female 10. Prior total gastrectomy 11. Previous radio- or radiochemotherapy, previous transarterial chemoembolisation (TACE), radiofrequency ablation (RFA) or selective intraarterial radiotherapy (SIRT) within 3 months prior to inclusion (except radiation for bone metastases) 12. Patients who might be dependent on the sponsor, site or the investigator 13. Persons held in an institution by legal or official order 14. Liver cirrhosis, except Child-Pugh A 15. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts 16. Participation in another study with ongoing use of unlicensed investigational product from 28 days or <5 half-lifes of the investigational product before study enrollment

Intensitätsmodulierte und bildgestützte Strahlentherapie bei Kopf-Hals-Tumore-Patienten: Erfassung und Reduktion von Geschmacksveränderungen/-verlusten im Therapieverlauf

ISRCTN | NCT
Intensitätsmodulierte und bildgestützte Strahlentherapie bei Kopf-Hals-Tumore-Patienten: Erfassung und Reduktion von Geschmacksveränderungen/-verlusten im Therapieverlauf
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Kopf-Hals-Karzinom
Studienzentrum: Universitätsklinikum Bonn, Klinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum Strahlentherapie Radioonkologie
Weitere Informationen anzeigen
Diagnose (ICD-10-GM): C00-C14, C32
Diagnose: Kopf-Hals-Karzinom
Alter: ab 18
Primäres Studienziel
Ziel ist die Entwicklung von Grenzwerten für die Zungendosis, bei deren Unterschreitung die Geschmacksverluste / --veränderungen seltener auftreten.
Sekundäre Studienziele
Ziel unserer Studie ist: 1. die im Zungenbereich ankommende Bestrahlungsdosis zu Beginn so zu reduzieren, dass bei Ihnen Veränderungen und Verluste des Geschmackssinns spät oder gar nicht auftreten. 2. mithilfe einer kontinuierlichen Befragung und Untersuchung den Ablauf von Geschmacksveränderungen und - verlusten besser zu dokumentieren und einen Zusammenhang mit der Bestrahlungsdosis herzustellen.
Einschlusskriterien
1. klinische Indikation zur adjuvanten oder definitiven Strahlentherapie bei Kopf-Hals-Tumor 2. Bereitschaft zur Teilnahme an der Studie und Unterzeichnen einer Einverständniserklärung 3. Alter mindestens 18 Jahre
Ausschlusskriterien
1. Vor Therapiebeginn, von der aktuellen Tumorerkrankung unabhängig vorliegende Geschmacksstörungen jeglicher Art 2. Schwangerschaft 3. fehlende Geschäftsfähigkeit

 
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