Best-of-EORTC 1420
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Title in German |
Phase III Studie zur Beurteilung der Strahlentherapie (IMRT) im Vergleich zur minimal invasive Chirurgie (trans-orale Laser- oder Roboter-gestützte Chirurgie, (TLM, TORS)) bei Patienten mit T1–2N0-1 Oropharynxkarzinomen, T1-2N0-1 supraglottischen Larynxkarzinomen und T1N0 Hypopharynxkarzinomen Studie zur Klärung der besten Therapie bei Rachenkrebs im Frühstadium. |
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Title in English |
EORTC 1420 - Phase III study assessing the “best of” radiotherapy compared to the “best of” surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0 oropharyngeal carcinoma. |
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Description |
The study examines the extent to which surgery or radiation therapy influences the recovery of normal swallowing function after treatment of an early-stage malignant tumor in the pharynx. |
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Both forms of treatment are already being used successfully today, but so far there has been no clarification as to which therapy is better with regard to swallowing function. |
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This study is being carried out jointly at several clinics in Switzerland and Europe. 170 patients are to be treated and examined as part of the study within 2 years. |
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Phase/Biobank/etc. |
Phase III |
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Studienleiter |
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Status |
19.12.2017 |
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BASEC-Nummer |
2017-01600 |
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KOFAM |
SNCTP000002375 |
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WHO-Register-Nummer |
NCT02984410 |
DeIntensiF
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Title in German |
Vergleich einer individualisierten Nachsorge mit verstärkter Patient*innen-Mitwirkung und verminderten Standard-Kontrollen mit der herkömmlichen Nachsorge nach einer auf vollständige Heilung ausgerichteten Behandlung von Kopf-Hals-Krebs |
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Title in English |
DeintensiF: Multicenter randomized trial comparing an individualized de-intensified and conventional follow-up strategy after curative treatment in head and neck cancer |
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Descpription |
This study is primarily intended to examine the difference between individualized follow-up care with increased patient involvement and reduced standard controls and conventional standard follow-up care in patients with moderately to severely advanced head and neck cancer from 6 months after complete treatment Cure-oriented treatment and complete clinical and imaging disappearance of the tumor. |
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Phase/Biobank/etc. |
Pilot study |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active since 12.10.2022 |
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BASEC-Nummer |
2022-00966 |
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KOFAM |
SNCTP000005198 |
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WHO-Register-Nummer |
ClinicalTrials.gov ID: NCT05388136 |
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Insel-Nummer |
DLF-Nr: 5240 |
LBB-FUP
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Title in German |
Flüssige Biopsien für die Nachsorge der Patienten mit Kopf- und Halskrebs |
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Title in English |
Circulating Biomarkers to Monitor Therapeutic Response of Head and Neck Cancer |
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Description |
With this research project we would like to determine the diagnostic value of so-called liquid biopsies in the context of tumor follow-up for patients with head and neck cancer. A liquid biopsy is used to obtain information about cancer from a blood sample. Above all, we would like to know whether it is possible to examine and monitor the disease using liquid biopsy-based methods. In the future, liquid biopsy could potentially also be used for early detection of cancer and cancer relapses. |
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So far, liquid biopsy-based tests have mostly been experimental and not standard procedures. They should therefore be used in clinical studies. To achieve this goal, we will compare the analyzes of the liquid biopsies with the results of the imaging and, if necessary, the tissue samples. This pilot study will only be carried out in the Inselspital and we would like to recruit around 30 patients in the first phase. |
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Phase/Biobank/etc. |
Biobank |
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Studienleiter |
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Status |
active since 01.09.2019 |
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BASEC-Nummer |
20189-00764 |
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KOFAM |
keine |
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WHO-Register-Nummer |
keine |
LBB-TOX
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Title in German |
Blutproben zur Vorhersage von Radio-Chemotherapie-Nebenwirkungen bei Patienten mit fortgeschrittenem Kopf-Hals-Tumor |
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Title in English |
A single-cell proteomics approach to predict chemoradiation-induced toxicities in patients with advanced head and neck squamous cell carcinoma |
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Description |
With this research project we would like to determine the diagnostic value of blood samples in the context of tumor therapy for patients with head and neck cancer. A blood sample is used to obtain information about cancer. Above all, we would like to know whether it is possible to predict the disease or side effects of the therapy using blood sample-based methods. So far, the tests with blood samples have mostly been experimental and not a standard procedure. They should therefore be used in clinical studies. To achieve this goal, we will compare the analyzes of the blood samples with the occurrence of side effects of therapy and imaging of the disease status after 4 months. This pilot study will only be carried out in the Inselspital and we would like to include around 30 patients in the first phase. |
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Phase/Biobank/etc. |
Biobank |
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Studienleiter |
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Status |
active since 23.01.2020 |
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BASEC-Nummer |
2019-00863 |
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KOFAM |
keine |
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WHO-Register-Nummer |
keine |
POLARES
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Title in German |
Personalisierte Plattform zur molekularen Charakterisierung von Kopf-Hals-Tumoren und Tumorrezidiven |
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Title in English |
Personalized discovery and validation multi-Omics pLAtform for Recurrent hEad and Neck Squamous Cell Carcinoma (POLARES) |
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Description |
In this project, the collected biological material will be examined in order to gain further knowledge in the area of the cause, detection and treatment of tumor diseases in the head and neck area. The biological material obtained in this way is linked to the associated personal and treatment data. |
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Phase/Biobank/etc. |
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Heads Clinical Trial |
Prof. Carsten Riether, PhD (Riether Lab); PD Dr. Michaela Medová (Medova Lab); Dr. med. Simon Häfliger (Häfliger Lab); Prof. Dr. med. Roland Giger (HNO) |
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Study-Nurse |
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Back-up |
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Status |
active since 04.10.2022 |
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BASEC-Nummer |
2022-00543 |
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KOFAM |
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WHO-Register-Nummer |
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Insel-Nummer |
VoiceDetect
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Title in German |
Die Stimme zur Erkennung von Kehlkopf- und Rachenkrebsrückfällen - eine Machbarkeitsstudie |
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Title in English |
The Voice as a tool to Detect recurrence of laryngeal and hypopharyngeal cancer - a feasibility study |
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Description |
The aim of this research project is to examine the feasibility of long-term, regular voice monitoring in laryngeal and hypopharyngeal cancer patients, particularly with regard to their follow-up adherence. All patients with squamous cell carcinoma of the larynx/hypopharynx (exclusively after total laryngectomy) who have successfully completed primary curative treatment 6-30 months ago will receive three-monthly voice recordings and fiber endoscopic examinations (examination using a flexible camera) over a period of at least six months. carried out. In addition, a subjective assessment of the patient's own voice problems is carried out at each study visit using the Voice Handicap Index 30 questionnaire. Ultimately, it is about determining and analyzing intra-individual voice changes, i.e. voice changes in patients over time, and correlating these objective voice changes with the subjective voice changes (questionnaire) and the clinical changes in the larynx/hypopharynx (flexible camera examination). |
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Phase/Biobank/etc. |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active since 01.07.2023 |
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BASEC-Nummer |
2023-00838 |
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KOFAM |
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WHO-Register-Nummer |
ClinicalTrials.gov ID:NCT05894070 |
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Insel-Nummer |
VoiceS
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Title in German |
VoiceS: Stimmqualität nach transoraler CO2-Lasermikrochirurgie im Vergleich zur singulären Stimmbandbestrahlung bei einseitigem glottischem Frühkarzinom – Multizentrische randomisierte Phase III Studie |
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Title in English |
VoiceS: Voice Quality after Transoral CO2-Laser Surgery versus Single Vocal Cord Irradiation for Unilateral Stage 0 & I Glottic Larynx Cancer – A Randomized Phase III Trial |
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Description |
There are two equivalent treatment options for early-stage vocal fold carcinoma: endoscopic laser surgery or radiation therapy. According to medical literature, both treatment options show comparable results in terms of chances of curing the tumor and voice quality. However, all studies conducted and published to date have been carried out using less than ideal methodology. Patients who were evaluated in these studies either actively decided on one of the two types of therapy themselves or their “correct” treatment was given to them by the treating physicians. |
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Our study focuses primarily on long-term voice quality. As part of this study, the type of therapy for each patient (surgery or radiotherapy) is determined not by the doctors or the patients themselves, but by a random generator using a computer program. This results in a study with greater scientific validity. |
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Today, surgical and radiotherapeutic treatments are carried out using the most modern organ-preserving techniques and are regularly checked for quality. The biostatistical calculations carried out in advance show that 34 patients are needed to complete the study successfully and with a sufficiently high level of significance. In each canton in which the study is carried out, a review is carried out by the responsible ethics committee. |
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Phase/Biobank/etc. |
Phase III |
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Studienleiter |
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Status |
active since 15.01.2020 |
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BASEC Nummer |
2019-01506 |
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KOFAM |
SNCTP000003599 |
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WHO-Register-Nummer |
NCT04057209 |