UCI – Das Tumorzentrum Bern - Navigation

Clinical Trials of the Department of Radiation Oncology

Head and neck tumours

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
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
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.
Phase/Biobank/etc.	Pilot study
Head Clinical Trial	Prof. Dr. med. Roland Giger (HNO)
Study-Nurse	Sandra Fuchser, Timo Nannen
Back-up
Status	active since 12.10.2022
BASEC-Nummer	2022-00966
KOFAM	SNCTP000005198
WHO-Register-Nummer	ClinicalTrials.gov ID: NCT05388136
Insel-Nummer	DLF-Nr: 5240

Title in German	Flüssige Biopsien für die Nachsorge der Patienten mit Kopf- und Halskrebs
Title in English	Circulating Biomarkers to Monitor Therapeutic Response of Head and Neck Cancer
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.
	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.
Phase/Biobank/etc.	Biobank
Studienleiter	Dr. med. Olgun Eliçin
Status	active since 01.09.2019
BASEC-Nummer	20189-00764
KOFAM	keine
WHO-Register-Nummer	keine

Title in German	Personalisierte Plattform zur molekularen Charakterisierung von Kopf-Hals-Tumoren und Tumorrezidiven
Title in English	Personalized discovery and validation multi-Omics pLAtform for Recurrent hEad and Neck Squamous Cell Carcinoma (POLARES)
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.
Phase/Biobank/etc.
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)
Study-Nurse
Back-up
Status	active since 04.10.2022
BASEC-Nummer	2022-00543
KOFAM
WHO-Register-Nummer
Insel-Nummer

Title in German	Untersuchung von Strahlungstherapie-assoziierten Speichel- und Geschmacks- veränderungen bei Kopf-Hals-Tumorpatienten
Title in English	Therapy-Associated Saliva and Taste change Evaluation (TASTE) in head and neck cancer patients undergoing radiotherapy
Description	Geschmacksveränderungen sind eine häufige Begleiterscheinung unter Bestrahlung bei Kopf-Hals-Tumorpatienten, welche auch nach Ende der Therapie in vielen Fällen weiter fortbestehen. Die genauen Ursachen dieser Geschmacksveränderungen sind allerdings weiter unklar. In unserem Forschungsvorhaben wollen wir daher herausfinden, inwiefern eine Strahlentherapie und die damit verbundenen Speichelveränderungen Einfluss auf den Geschmacksinn haben.
Phase/Biobank/etc.
Head Clinical Trial	Prof. Dr. med. Olgun Elicin
Study-Nurse
Back-up
Status	active since 05.09.2022
BASEC-Nummer	2022-00706
KOFAM
WHO-Register-Nummer	NCT06444776
Insel-Nummer

Title in German	VoiceS: Stimmqualität nach transoraler CO2-Lasermikrochirurgie im Vergleich zur singulären Stimmbandbestrahlung bei einseitigem glottischem Frühkarzinom – Multizentrische randomisierte Phase III Studie
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
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.
	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.
	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.
Phase/Biobank/etc.	Phase III
Studienleiter	Prof. Dr. med. Olgun Elicin
Status	active since 15.01.2020
BASEC Nummer	2019-01506
KOFAM	SNCTP000003599
WHO-Register-Nummer	NCT04057209

Lung and thorax tumours

Title in German	PRophylaktische Hirnbestrahlung oder aktive MAgnetresonanztomografische Überwachung von Patienten mit kleinzelligem Lungenkarzinom (PRIMALung-Studie)
Title in English	PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Description	Patients with small cell lung cancer are usually treated with a combination of chemotherapy and radiation to the chest, and in some cases additional immunotherapy (drugs that stimulate the body's immune system).
	If the carcinoma spreads to the rest of the body (metastases), in many cases the brain is affected. Although brain irradiation is accepted as standard of care, current concerns about nervous system damage and the possibility of brain MRIs (magnetic resonance imaging) may make active monitoring a potentially better alternative to routine brain irradiation. In addition, there are open questions to be clarified about the role and timing of brain irradiation with increased use of immunotherapy.
	The aim of this study is to find out whether active surveillance via brain MRIs (magnetic resonance imaging) detects potential metastases in the brain earlier and leads to appropriate treatment without having a negative impact on survival compared to brain radiation when used in addition to brain metastases MRI monitoring is done.
	To find out whether the results of active monitoring via brain MRI are not caused purely by chance, we need to compare data from patients who were actively followed up via brain MRI with those from patients who received preventative brain irradiation.
	Therefore, the study participants are randomly assigned to one of two groups. One group receives daily preventive brain radiation for approximately 2 weeks and is then actively followed up via brain MRIs for up to 2 years. The other group will be actively followed up exclusively via brain MRIs for up to 2 years.
Phase/Biobank/etc.
Head Clinical Trial	Prof. Dr. med. Olgun Elicin
Study-Nurse
Back-up
Status	aktive since 27.10.2022
BASEC-Nummer	2022-00157
KOFAM	SNCTP000004998
WHO-Register-Nummer	NCT04790253
Insel-Nummer	5206

Neuro-oncological tumours

Title in German	ETOP 19-21 USZ-STRIKE
Title in English	ETOP 19-21 USZ-STRIKE
Description	Immunotherapy or targeted therapy with or without stereotactic radiosurgery in patients with brain metastases from melanoma or non-small cell lung cancer.
Phase	III
Head Clinical Trial	Dr. med. Ekin Ermis
Study Coordinator	Sandra Fuchser
Back-up	Timon Nannen
Status	aktive
BASEC-Nummer	2022-01064
Nummer aus Studienregister (z.B. clinicaltrials.gov)	NCT05522660
WHO-Register-Nummer
Insel-Nummer	5406

Title in German	Eine multizentrische prospektive, interventionelle, randomisierte Studie zur präoperativen Radiochirurgie im Vergleich zur postoperativen stereotaktischen Strahlentherapie bei resektablen Hirnmetastasen.
Title in English	A multicentre prospective, interventional, randomised trial of preoperative radiosurgery compared with postoperative stereotactic radiotherapy for resectable brain metastases.
Description	For brain metastases (offshoots of cancer in the brain) when they reach a certain size, different treatments are used. Currently, at the Inselspital Bern, the metastasis is first operated on and then (post-operatively) the region in which the metastasis was located (so-called “tumor bed”) is irradiated for 5 days. In some other clinics the opposite approach is also carried out, i.e. a single radiation treatment is carried out before the operation (so-called pre-operative). In our research project, we want to find out whether the return of metastases (recurrences) from the tumor bed is equally common in both forms of treatment and how patients experience the therapies (quality of life).
Phase/Biobank/etc.	III
Head Clinical Trial	Dr. med. Ermis Ekin
Study-Nurse
Back-up
Status	active since 02.06.2022
BASEC-Nummer	2021-02094
Nummer aus Studienregister	Clinicaltrials.gov: NCT 05124236
Insel-Nummer	5139

Urogenital tumours

Title in German	Studie zur Sicherheit und Wirksamkeit einer gezielten, hochdosierten Bestrahlung eines einzelnen wiederauftretenden Tumorknotens im Prostatabett nach ursprünglicher Prostataentfernung
Title in English	A single arm phase II trial for ultrahypofractionted salvage radiotherapy for isolated prostate bed recurrence after radical prostatectomy
Description	If prostate cancer recurs in the area of the former prostate, radiotherapy to the prostate bed is carried out as standard with a certain dose and a targeted increase in dose to the visible tumor that has recurred (local recurrence) in combination with parallel anti-hormonal therapy in order to prevent the progression of the disease. In our research project, we want to find out whether high-dose targeted radiation therapy for local recurrence with parallel antihormonal therapy has the same safety and effectiveness.
Phase/Biobank etc.	Phase II
Head Clinical Trial	PD Dr. med. M. Shelan
Study-Nurse
Back-up
Status	active since 27.2.2023
BASEC Nummer	2022-01026
KOFAM	SNCTP000005372
WHO-Register-Nummer	NCT05746806
Insel-Nummer

Title in German	Wirksamkeit des SpaceOAR Vue-Systems bei Patienten mit Prostatakrebs, die mit der stereotaktischen Körperstrahlentherapie (SABRE) behandelt werden (U0702)
Title in English	Effectiveness of the SpaceOAR Vue System in Subjects with Prostate Cancer being Treated with Stereotactic Body RadiothErapy (SABRE)
Description	This study aims to investigate the effectiveness of the SpaceOAR medical device. The SpaceOAR Vue system is a hydrogel that creates a space between the rectum and the prostate, which can help minimize the side effects of cancer radiation therapy.
	The prostate is located next to the rectum and is naturally separated by a small space called the perirectal space. – The SpaceOAR Vue System Hydrogel is inserted into the space between the rectum and prostate using a needle. Because of the proximity, prostate radiotherapy can inadvertently cause damage to the rectum, which can lead to problems with bowel function. – By acting as a spacer, the hydrogel temporarily moves the rectum away from the prostate. By separating the rectum from the prostate, the SpaceOAR Vue system reduces the amount of radiation received by the rectum and can reduce damage to the rectum.
	Patients are assigned to one of two groups by a computer program; Approximately 333 study participants will receive the SpaceOAR Vue System Hydrogel and are considered part of the treatment group and approximately 167 will not receive the SpaceOAR Vue System Hydrogel and are considered part of the control group. The treatment group may also receive reference markers to support radiotherapy. The reference markers are placed at the physician's discretion. – Stereotactic radiation (SBRT) is then administered. The control group may also receive fiducial markers to support radiotherapy, but not the SpaceOAR Vue System, at the physician's discretion. Stereotactic radiation is then administered.
	Data will be collected and recorded before, during and after SBRT treatment. These visits occur at 3, 6, 12, 18, 24, 36, 48 and 60 months after the start of radiotherapy. Participation in the study is completed after 5 years.
Phase/Biobank etc.
Head Clinical Trial	PD Dr. med. M. Shelan
Study-Nurse
Back-up
Status	Aktive since 01.04.2023
BASEC Nummer	2022-D0042
KOFAM	SNCTP000005130
WHO-Register-Nummer	NCT04905069
Insel-Nummer

Title in German	Radio-Chemotherapie mit reduzierter Intensität bei Patienten mit einem Seminom (Hodenkrebs) des Stadiums IIA/B. Eine multizentrische, offene Phase-II-Studie mit zwei Patientengruppen
Title in English	Reduced intensity radio-chemotherapy for stage IIA/B seminoma. A multicenter, open label phase II trial with two cohorts
Description	The study will examine whether and how the treatment of men with seminoma (testicular cancer) can be improved. In the study, patients will be treated with a combination of chemotherapy and radiation therapy at reduced intensity. We want to find out whether this form of attenuated therapy is effective compared to usual therapy, whether possible side effects can be avoided and how this affects patients' quality of life.
	This study is being carried out in Switzerland and Germany. A total of around 135 patients are taking part. The drugs used in the study as chemotherapy are carboplatin (stage IIA) and cisplatin/etoposide (stage IIB and IIA), which are common in the treatment of testicular cancer in Switzerland. The study therapy lasts around six weeks. Each participant will then be monitored at regular intervals for 20 years.
Phase/Biobank/ect.	Phase II
Head Clinical Trial	PD Dr. med. Mohamed Shelan
Co-Investigator	Prof. Dr.med. Jörg Beyer
Back-up	Antje Kramer
Status	aktive since 18.07.2019
BASEC Nummer	2019-00796
KOFAM	SNCTP000003335
WHO-Register-Nummer	NCT02051218

Other trials

Title in German	Täglich angepasste Strahlentherapie bei Speiseröhrenkrebs (ARTEC)
Title in English	Conebeam CT-based online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC)
Description	Bei Speiseröhre-Tumoren wird eine kombinierte Bestrahlung und Chemotherapie, gefolgt von der Operation als Standardtherapie durchgeführt, um die Überlebensrate im Vergleich zur alleinigen Operation zu verbessern. In unserem Forschungsvorhaben wollen wir herausfinden, ob eine täglich angepasste Strahlentherapie die Nebenwirkung der Therapie vermindert. Wir nennen dieses Verfahren "Online-adaptive Strahlentherapie (OART)". Aktuell und ausserhalb der Studie verwenden wir die OART für Patienten mit Speiseröhre- Tumoren als Standardtherapie in der Universitätsklinik für Radio-Onkologie des Inselspitals.
Phase/Biobank etc.
Head Clinical Trial	Dr. med. H. Hemmatazad
Study-Nurse
Back-up
Status	Active since 14.02.2024
BASEC Nummer	2023-01833
KOFAM
WHO-Register-Nummer	NCT06361043
Insel-Nummer

Title in German	Randomisierte Studie zur Evaluierung der Wirksamkeit einer regionalen Tiefenhyperthermie bei Patienten mit Analkarzinom, die durch eine Standard-Radiochemotherapie behandelt werden
Title in English	Randomized trial to evaluate effects of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy
Description	Die Studie untersucht eine Tumorerkrankung des Analkanals (Analkarzinom). Im Rahmen dieser Studie wollen wir kontrolliert (es gibt eine Studien- und eine Kontrollgruppe) prüfen, ob eine zusätzliche Hyperthermie die Erwartungen erfüllt, um sie zukünftig, bei positiven Ergebnis, routinemässig Patienten mit Analkarzinom anbieten zu können.
Phase/Biobank/etc.
Head Clinical Trial	Dr. med. E. Stutz
Study-Nurse
Back-up
Status	active since 24.06.2024
BASEC-Nummer	2020-02146
KOFAM	SNCTP000004203
WHO-Register-Nummer	NCT02369939
Insel-Nummer

Title in German	E²-RADIatE: EORTC-ESTRO RADiotherapie InfrAstrukTur für Europa
Title in English	E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe
Description	This study is being conducted to collect information about radiation treatments. The goal is to link patient information with treatment data and imaging data. The aim is to recognize patterns and identify factors that influence patient care and the success of treatment.
	This information can be used to improve standard treatments and learn how to better introduce new technologies into routine practice. The information is used to answer many research questions. Your doctor can inform you about the research question for which your data is being collected. Your data may be used for more than one research question.
Phase/Biobank/etc.	Registerstudie
Head Clinical Trial	Dr. med. H. Hemmatazad
Status	active since 23.10.2019
BASEC-Nummer	2019-00640
KOFAM	keine
WHO-Register-Nummer	keine

Title in German	Gezielte Bestrahlung kleiner neuer metastatischer Läsionen während der Standardbehandlung bei soliden Krebs
Title in English	Stereotactic body radiotherapy in addition to standard of care treatment in patients with rare oligometastatic cancers (OligoRARE): a randomized, phase 3, open-label trial
Description	Oligometastasis is generally considered an intermediate state between local and distant metastatic (spreading to the rest of the body) cancer, with a limited number of metastases and organs involved.
	Retrospective studies (studies of patients who have been treated in the past) have shown that aggressive treatment (surgery or radiation) of metastases added to standard systemic therapy achieved longer survival in about a quarter of patients.
	Technical developments in radiation therapy now make it possible to deliver targeted high doses of radiation. This so-called stereotactic radiation therapy (SBRT) has become the standard for oligometastatic disease, treating different anatomical sites (e.g. lung and liver). In addition, SBRT is a non-invasive treatment that is carried out in a few outpatient sessions and therefore allows systemic therapy to be continued.
	OligoRare is aimed at patients with oligometastases of all solid cancers except lung, breast, colon and prostate. The primary objective is to assess whether adding SBRT to standard of care improves overall survival in patients with “oligometastatic rare” cancers. Patients with a maximum of 5 oligometastases are treated according to standard of care with or without the addition of SBRT. The standard includes chemotherapy, targeted therapy (agents that specifically attack cancer cells), hormone therapy, immunotherapy (agents that stimulate the body's natural defenses), or observation. Patients will be followed every 3 months for the first 2 years and every 6 months for the next 3 years.
Phase/Biobank/etc.	Phase III
Head Clinical Trial	Dr. med. H. Hemmatazad
Status	active since August 2021
BASEC-Nummer	2021-00693
KOFAM	SNCTP000004459
WHO-Register-Nummer	NCT04498767

Title in German	Vergleich zweier Bestrahlungsschemata zur Behandlung von Knochenmetastasen ausserhalb der Wirbelsäule
Title in English	Stereotactic multiple fraction radiotherapy for non-spine bone metastases - SMILE
Description	With this study we want to investigate whether high-precision radiotherapy over 3 sessions with 9 Gy per session within a week works as well as high-precision radiotherapy over 5 sessions with 7 Gy per session within a week.
Phase/Biobank etc.
Head Clinical Trial	Dr. med. H. Hemmatazad
Study-Nurse
Back-up
Status	Aktive since 07.12.2022
BASEC Nummer	2022-00631
KOFAM	SNCTP000004897
WHO-Register-Nummer	NCT05406063
Insel-Nummer