Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer
- Conditions
- Oligometastatic Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Radiation: stereotattic ablation radiotherapy (SABR)
- Registration Number
- NCT05815927
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 : Standard of Care + stereotattic ablative radiation (SABR) stereotattic ablation radiotherapy (SABR) The Experiemnt Arm consists of pembrolizumab at a dose of 400mg every 6-weeks (Q6W) for a duration of 2 years (i.e 17 cycles) as per Standard of Care treatment of oligometastatic HNSCC disease in combination with SABR. For each oligometastatic lesion treatment, specific SABR fractions and targeted dose(Gy) should be used depending on the location of the lesion. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments have to be completed within 10 working days. Arm 1 : Standard of Care Pembrolizumab Pembrolizumab at a dose of 400mg every 6-weeks (Q6W) for a duration of 2 years (i.e 17 cycles) as per Standard of Care treatment of oligometastatic HNSCC disease. Palliative radiotherapy to oligometastatic disease is allowed if necessary as per standard of care to relieve symptomatic disease and prevent complications. Recommended dose regimens are 1x 8 Gy, 5x 4 Gy and 10x 3 Gy. Planning technique and target volume definition should be according to institutional standards.No ablative-stereotactic dose and no boost techniques are allowed with the exception of CNS-metastases treatment. Arm 2 : Standard of Care + stereotattic ablative radiation (SABR) Pembrolizumab The Experiemnt Arm consists of pembrolizumab at a dose of 400mg every 6-weeks (Q6W) for a duration of 2 years (i.e 17 cycles) as per Standard of Care treatment of oligometastatic HNSCC disease in combination with SABR. For each oligometastatic lesion treatment, specific SABR fractions and targeted dose(Gy) should be used depending on the location of the lesion. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments have to be completed within 10 working days.
- Primary Outcome Measures
Name Time Method Progression-free survival by RECIST 1.1 2.6 years after first patient in To assess whether SABR added to pembrolizumab improves progression-free survival in patients with HNSCC disease, PD-L1 CPS ≥1 and 1-5 metastatic lesions, as compared to pembrolizumab alone.
- Secondary Outcome Measures
Name Time Method Time to disease progression 5.2 years after first patient in To assess whether SABR added to pembrolizumab improves time to disease progression
Time to development of new metastatic lesions 5.2 years after first patient in To assess whether SABR added to pembrolizumab improves time to development of new metastatic lesions
Disease-specific survival 5.2 years after first patient in To assess whether SABR added to pembrolizumab improves disease-specific survival
Time to progression in oligometastatic lesions initially present at enrolment 5.2 years after first patient in To assess whether SABR added to pembrolizumab improves time to progression in oligometastatic lesions initially present at enrolment
Overall survival 5.2 years after first patient in To assess whether SABR added to pembrolizumab improves OS
Adverse events according to CTCAE version 5.0 5.2 years after first patient in To evaluate the safety and tolerability according to CTCAE v5.0 of SABR combined with pembrolizumab
Health-related quality of life evaluated using self-administered EORTC QLQ-HN43 questionnaire 5.2 years after first patient in Health-related quality of life evaluated using self-administered EORTC IL-198 questionnaire 5.2 years after first patient in Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaire 5.2 years after first patient in
Trial Locations
- Locations (26)
AUSL Romagna - AUSL Della Romagna -Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
Azienda ospedaliero Univ Policlinico Umberto I
🇮🇹Rome, Italy
Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia
🇪🇸Barcelona, Spain
ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
🇪🇸Barcelona, Spain
Inselspital - Inselspital
🇨🇭Bern, Switzerland
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan
🇧🇪Kortrijk, Belgium
CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur
🇧🇪Namur, Belgium
VITAZ St Niklaas - VITAZ- Oncology
🇧🇪Sint Niklaas, Belgium
Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA)
🇧🇪Wilrijk, Belgium
IRCCS--Ospedale Bellaria-Bologna
🇮🇹Bologna, Italy
AUSL - Ospedale Infermi
🇮🇹Faenza, Italy
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi
🇮🇹Florence, Italy
AUSL -Ospedale Umberto I
🇮🇹Lugo, Italy
Istituto Clinico Humanitas
🇮🇹Milan, Italy
IRCCS - Fondazione Istituto Nazionale dei Tumori
🇮🇹Milan, Italy
Azienda Sanitaria Locale Napoli 1 Centro
🇮🇹Napoli, Italy
Hospital Universitario de Gran Canaria Doctor Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Luzerner Kantonsspital
🇨🇭Luzern, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
UniversitaetsSpital Zurich
🇨🇭Zürich, Switzerland