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SNCTP000003964 | NCT03721341 | BASEC2020-00300

Eine randomisierte Phase-III-Studie zur stereotaktischen Strahlentherapie für die Behandlung von 4 bis 10 Metastasen

Data source: BASEC (Imported from 25.09.2020), WHO (Imported from 20.09.2020)
Changed: 18.08.2020
Disease category: Other Cancer, Other

Brief description of trial (Data source: BASEC)

Mit der SABR-COMET 10-Studie will man herausfinden, ob die stereotaktische Strahlentherapie aller Metastasen der Standardbehandlung überlegen ist. Die Standardbehandlung besteht aus der Strahlentherapie von Metastasen, die Beschwerden bereiten und solchen, die bald zu Beschwerden führen könnten.
Neben der Strahlentherapie kann in beiden Behandlungsgruppen zusätzlich eine systemische Therapie erfolgen, so zum Beispiel eine Chemotherapie oder eine Hormontherapie. Ob Sie eine solche systemische Therapie erhalten wird vom behandelnden Onkologen individuell entschieden.
In welche Behandlungsgruppe sie eingeteilt werden, wird durch Zufall bestimmt. Die Chance der Behandlungsgruppe mit der stereotaktischen Bestrahlung aller Metastasen zugeteilt zu werden beträgt 2/3. Die Studienteilnahme dauert 5 Jahre, wobei die meisten der Besuchstermine Teil der standardmässigen klinischen Therapie und Nachsorge sind.

Health conditions investigated (Data source: BASEC)

Metastasierende Krebserkrankung mit 4 bis 10 Metastasen

Health conditions (Data source: WHO)

Metastatic Tumors

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Die stereotaktische Bestrahlung ist eine Form der Strahlentherapie, bei der Tumore mit hohen Dosen in wenigen Behandlungen sehr präzise bestrahlt werden. In der experimentellen Behandlungsgruppe werden alle Metastasen mit dieser Therapie behandelt. Die maximale Dauer der Bestrahlung ist zwei Wochen.

Interventions (Data source: WHO)

Drug: Chemotherapy
Drug: Hormones
Drug: Immunotherapy
Other: Observation
Radiation: Palliative Radiation
Radiation: Stereotactic Ablative Radiotherapy

Criteria for participation in trial (Data source: BASEC)

•18 Jahre und älter
•Guter Allgemeinzustand
•4 bis 10 Metastasen, die alle sicher behandelt werden können mit der stereotaktischen Bestrahlung.

Exclusion criteria (Data source: BASEC)

•Schwerwiegende medizinische Komorbiditäten oder Funktionsstörungen, die eine Strahlentherapie ausschliessen.
•Frühere Strahlentherapie, bei der es zu Überschneidungen mit der geplanten Strahlentherapie kommt und Grenzwerte für die Strahlendosis überschritten würden.
•Einzelne Metastasen die grösser als 5cm sind und im Fall von Hirnmetastasen grösser als 3cm sind.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Age 18 or older

- Willing to provide informed consent

- Karnofsky performance score greater than 60

- Life expectancy greater than 6 months

- Histologically confirmed malignancy with metastatic disease detected on imaging.
Biopsy of metastasis is preferred, but not required.

- Controlled primary tumor defined as: at least 3 months since original tumor treated
definitively, with no progression at primary site

- Total number of metastases 4-10

- All sites of disease can be safely treated based on a pre-plan

Exclusion Criteria:

- Serious medical comorbidities precluding radiotherapy. These include interstitial lung
disease in patients requiring thoracic radiation, Crohn's disease in patients where
the GI tract will receive radiotherapy, and connective tissue disorders such as lupus
or scleroderma.

- For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or
C)

- Substantial overlap with a previously treated radiation volume. Prior radiotherapy in
general is allowed, as long as the composite plan meets dose constraints herein. For
patients treated with radiation previously, biological effective dose calculations
should be used to equate previous doses to the tolerance doses listed below. All such
cases must be discussed with one of the study PIs.

- Malignant pleural effusion

- Inability to treat all sites of disease

- Any single metastasis greater than 5 cm in size.

- Any brain metastasis greater than 3 cm in size or a total volume of brain metastases
greater than 30 cc.

- Metastasis in the brainstem

- Clinical or radiologic evidence of spinal cord compression

- Dominant brain metastasis requiring surgical decompression

- Metastatic disease that invades any of the following: GI tract (including esophagus,
stomach, small or large bowel), mesenteric lymph nodes, or skin

- Pregnant or lactating women

Minimum age: 18 Years
Maximum age: N/A
Sex: All

Further information on the trial in WHO primary registry

http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT03721341

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03721341

Further information on trial

Date trial registered

23.10.2018

Incorporation of the first participant

22.02.2019

Recruitment status

Recruiting

Global completion date of trial

30.11.-0001

Academic title (Data source: WHO)

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Overall Survival at Study Completion

Secundary end point (Data source: WHO)

Overall Survival at midpoint of Study
Progression-free Survival
Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire
Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire
Time from randomization to development of new metastatic lesions
Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
Canada

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof. Dr. med. Matthias Guckenberger
+41 44 255 27 13
matthias.guckenberger@usz.ch

Contact for general information (Data source: WHO)

David Palma, MD
London Health Sciences Centre, Lawson Health Research Institute

Contact for scientific information (Data source: WHO)

David Palma, MD
519-685-8650
David.Palma@lhsc.on.ca

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

David Palma

Additional sponsors (Data source: WHO)

Amsterdam University Medical Centre, VUmc Site
Beaston West of Scotland Cancer Centre
British Columbia Cancer - Centre for the North
London Health Sciences Centre

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

30.06.2020

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2020-00300

Secondary ID (Data source: WHO)

SABR-COMET 10