Condition: Oligometastatic Squamous Cell Carcinoma of the Head and Neck · Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
This is a randomized open-label multicentre phase III superiority study of the effect of adding SABR to the standard of care treatment pembrolizumab on progression free survival in patients with oligometastases of a squamous cell carcinoma of the head and neck (SCCHN), histological confirmation of the primary disease at first diagnosis, and PD-L1 CPS ≥1. After eligibility check and signing informed consent, all patients will be prospectively enrolled in a 1:1 ratio between current standard of care treatment (pembrolizumab, Arm 1) vs. SABR + standard of care treatment (Arm 2) to oligometastases. Any radical treatment to the synchronous primary/ recurrent primary tumor and/or involved cervical nodes (surgery or radiotherapy), as decided by the local tumor board/ treating physicians, should be completed prior to enrolment.Surgical removal of metastases is allowed for diagnostic purposes or for brain metastases, as long as these metastases count toward the total number of 5 and at least one metastasis is left for treatment with SABR. Such surgical procedures should be performed prior to enrolment.
This description comes directly from the study's public registry record.
EORTC HQ · +32 2 774 16 11 · eortc@eortc.org
Always discuss trial participation with your own doctor first.
| Cliniques Universitaires Saint-Luc | Brussels, Belgium | Recruiting |
| CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont | Haine-Saint-Paul, Belgium | Not Yet Recruiting |
| AZ Groeninge Kortrijk - Campus Kennedylaan | Kortrijk, Belgium | Recruiting |
| CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur | Namur, Belgium | Recruiting |
| VITAZ St Niklaas - VITAZ- Oncology | Sint-Niklaas, Belgium | Recruiting |
| Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA) | Wilrijk, Belgium | Recruiting |
| IRCCS--Ospedale Bellaria-Bologna | Bologna, Italy | Not Yet Recruiting |
| Azienda Ospedaliera Santa Croce E Carle | Cuneo, Italy | Not Yet Recruiting |
| Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi | Florence, Italy | Recruiting |
| Istituto Clinico Humanitas | Milan, Italy | Recruiting |
| IRCCS - Fondazione Istituto Nazionale dei Tumori | Milan, Italy | Recruiting |
| Azienda Sanitaria Locale Napoli 1 Centro | Naples, Italy | Not Yet Recruiting |
+ 18 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05815927