Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma

Launched by UNIVERSITY OF ZURICH · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating oropharyngeal cancer, which is a type of throat cancer that affects areas like the tonsils and the base of the tongue. The goal is to reduce the amount of radiation given to healthy tissues during treatment while still effectively targeting the cancer. Researchers want to see if this personalized method can lower the risk of the cancer coming back outside the treated areas, based on each patient's specific condition and risk factors.

To participate in this trial, you need to be at least 18 years old and have a newly diagnosed oropharyngeal squamous cell carcinoma that hasn’t been treated yet. You will also need to be scheduled for radiation therapy, which may include chemotherapy. The trial is currently recruiting participants, and your health will be carefully evaluated to ensure you qualify. Throughout the study, you can expect to receive regular check-ups and monitoring to assess your health and treatment outcomes. Your participation could help improve future cancer treatments by reducing side effects while maintaining effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.
• • Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes.
• • Age ≥ 18 years, no upper age limit.
• • ECOG performance score \< 3.
• • History/physical examination within 30 days prior to study inclusion by head and neck surgeon and/or radiation oncologist.
• • FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory.
• • Participants need to provide informed consent.
• Exclusion Criteria:
• Inclusion Criteria:
• • Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.
• • Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes.
• • Age ≥ 18 years, no upper age limit.
• • ECOG performance score \< 3.
• • History/physical examination within 30 days prior to study inclusion by head and neck surgeon and/or radiation oncologist.
• • FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory.
• • Participants need to provide informed consent.
• Exclusion Criteria:
• • Multilevel primary tumors extending unambiguously beyond the oropharynx into the oral cavity, naso- or hypopharynx
• • Distant metastases detected.
• • Previous surgery, chemotherapy or radiotherapy treatment for other head and neck cancers.
• • Previous surgery in head and neck region affecting the cervical lymphatic system. Dissection of singular lymph nodes for diagnostic purposes before treatment start is allowed.
• • Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active/progressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer).
• • Pregnancy or breast feeding
• • Any severe mental or psychic disorder affecting decision making and ability to provide informed consent.