Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma
- Conditions
- Oropharynx Cancer
- Registration Number
- NCT06563362
- Lead Sponsor
- University of Zurich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria:<br><br> - Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the<br> oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface<br> of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.<br><br> - Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of<br> the lymph nodes.<br><br> - Age = 18 years, no upper age limit.<br><br> - ECOG performance score < 3.<br><br> - History/physical examination within 30 days prior to study inclusion by head and<br> neck surgeon and/or radiation oncologist.<br><br> - FDG-PET scan prior to study inclusion. In case of inability to perform or<br> contra-indication, at least contrast enhanced MRI scan obligatory.<br><br> - Participants need to provide informed consent.<br><br>Exclusion Criteria:<br><br>Inclusion Criteria:<br><br> - Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the<br> oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface<br> of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.<br><br> - Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of<br> the lymph nodes.<br><br> - Age = 18 years, no upper age limit.<br><br> - ECOG performance score < 3.<br><br> - History/physical examination within 30 days prior to study inclusion by head and<br> neck surgeon and/or radiation oncologist.<br><br> - FDG-PET scan prior to study inclusion. In case of inability to perform or<br> contra-indication, at least contrast enhanced MRI scan obligatory.<br><br> - Participants need to provide informed consent.<br><br>Exclusion Criteria:<br><br> - Multilevel primary tumors extending unambiguously beyond the oropharynx into the<br> oral cavity, naso- or hypopharynx<br><br> - Distant metastases detected.<br><br> - Previous surgery, chemotherapy or radiotherapy treatment for other head and neck<br> cancers.<br><br> - Previous surgery in head and neck region affecting the cervical lymphatic system.<br> Dissection of singular lymph nodes for diagnostic purposes before treatment start is<br> allowed.<br><br> - Synchronous or previous malignancies. Exceptions are curatively treated basal cell<br> carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or<br> intermediate- risk prostate cancer or breast with a progression-free follow-up time<br> of at least 3 years without any remaining disease burden, or other previous<br> malignancy with a progression-free interval of at least 5 years without any<br> remaining active/progressive disease burden regardless whether the treatment is<br> completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy<br> for prostate cancer).<br><br> - Pregnancy or breast feeding<br><br> - Any severe mental or psychic disorder affecting decision making and ability to<br> provide informed consent.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method out-of field nodal recurrence rate at 2 years
- Secondary Outcome Measures
Name Time Method out-of field nodal recurrence rate at 3 years;Loco-regional control (LCR) rate at 2 years;Loco-regional control (LCR) rate at 3 years;Progression-free survival (PFS) at 2 years;Progression-free survival (PFS) at 3 years;Overall Survival (OS) at 2 years;Overall Survival (OS) at 3 years;Early toxicity of treatment;Late toxicity of treatment;Overall Quality of life at end of treatment;Quality of life regarding head and neck specific symptoms at end of treatment;Overall Quality of life at 6 months after treatment;Quality of life regarding head and neck specific symptoms at 6 months after treatment;Overall Quality of life at 12 months after treatment;Quality of life regarding head and neck specific symptoms at 12 months after treatment;Overall Quality of life at 24 months after treatment;Quality of life regarding head and neck specific symptoms at 24 months after treatment