Radiotherapy Plus Xevinapant in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
- Conditions
- Locally Advanced Head and Neck Squamous Cell Carcinoma
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- Not specified
Main Inclusion Criteria:<br><br> - Age = 70 years.<br><br> - Pathologically proven new diagnosis of HNSCC of oral cavity, oropharynx, hypopharynx<br> and larynx tumor.<br><br> - cT3-4 cN0 cM0 or cT1-4 cN1-3 cM0 except for T1-2N1 p16 positive oropharyngeal cancer<br> (AJCC 8th edition).<br><br> - HPV status using p16 immunohistochemistry (IHC) available for oropharyngeal squamous<br> cell carcinoma.<br><br> - Measurable disease per RECIST 1.1.<br><br> - Eastern Coperative Oncology Group Performance Status (ECOG PS) = 1.<br><br> - Intention to treat with curative intent primary radiotherapy alone.<br><br> - Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy<br> or jejunostomy placed.<br><br> - Adequate hematologic, renal, and hepatic function as indicated by:<br><br> - Creatinine clearance = 30 mL/min, measured with the Cockroft and Gault formula.<br><br> - Absolute neutrophil count = 1 500 cells/µL.<br><br> - Platelets = 100 000 cells/µL.<br><br> - Hemoglobin = 9.0 g/dL or =5.6 mmol/L (blood transfusions during screening are<br> permitted).<br><br> - AST and ALT = 3.0 × upper limit of normal (ULN).<br><br> - Total bilirubin = 1.5 × ULN (up to 2.0 × ULN is allowed if the direct bilirubin<br> level is normal and the elevation is limited to indirect bilirubin).<br><br> - Written informed consent must be signed according to ICH/GCP, and national/local<br> regulations.<br><br>Main Exclusion Criteria:<br><br> - Unknown primary, primary nasopharynx and paranasal sinus.<br><br> - Two primaries.<br><br> - Any previous or current treatment for invasive head and neck cancer, including<br> induction chemotherapy, surgery, concomitant chemotherapy and cetuximab.<br><br> - Gastrointestinal disorders that could affect drug absorption.<br><br> - Another malignancy in the previous 3 years with exception of curatively treated<br> disease with no evidence of recurrence.<br><br> - Known allergy to xevinapant or any excipient known to be present in active or<br> placebo formulation.<br><br> - Active gastrointestinal bleeding, or any other uncontrolled bleeding requiring more<br> than 2 red blood cell transfusions or 4 units of packed red blood cells within 4<br> weeks prior to enrolment<br><br> - Non-Decompensated or symptomatic liver cirrhosis (Child-Pugh score: B or C).<br><br> - Impaired cardiovascular function or clinically significant cardiovascular diseases<br><br> - Any uncontrolled, intercurrent illness or clinical situation that would in the<br> judgment of investigator, limit compliance with study requirements. This includes<br> but is not limited to uncontrolled active infections, defined as any infection<br> requiring IV antibiotics within 7 days prior to enrolment.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Locoregional event-free survival (LREFS)
- Secondary Outcome Measures
Name Time Method Response to treatment by RECIST 1.1;Progression Free Survival as assessed by the local investigator;Overall Survival;Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting;HRQOL as assessed by global health/QoL and physical functioning scales at week 20 (Fatigue scale from the Quality of Life Core-30 (QLQ-C30) and pain in the head and neck scale from Item List-225 (IL225)).