Reducing radiation volume in oropharyngeal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a personalized approach to reduce the volume of elective nodal irradiation in patients with oropharyngeal squamous cell carcinoma. By utilizing a multicentric dataset, the study aims to tailor the radiation treatment based on individual patient characteristics and disease progression, potentially minimizing the risk of toxicity associated with standard treatment. The feasibility of this de-escalation strategy will be assessed by monitoring the occurrence of out-of-field recurrences. The study includes patients who are newly diagnosed and planned for definitive (chemo) radiotherapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zurich University Hospital
  Zurich, Canton of Zurich, Switzerland Recruiting
• Cantonal Hospital Aarau
  Aarau, Switzerland Recruiting
• Ospedale Regionale di Bellinzona
  Bellinzona, Switzerland Recruiting
• Inselspital Bern
  Bern, Switzerland Recruiting
• Hôpitaux universitaires de Genève
  Geneva, Switzerland Recruiting
• Réseau Hospitalier Neuchâtelois
  Neuchâtel, Switzerland Recruiting

Study contacts

• Principal investigator: Panagiotis Balermpas, MD — University of Zurich
• Study coordinator: Panagiotis Balermpas, MD
• Email: Panagiotis.Balermpas@usz.ch
• Phone: +41 44 255 35 67

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.