Reducing radiation volume in oropharyngeal cancer treatment
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck
This study is testing a personalized way to reduce radiation for people with oropharyngeal cancer to see if it can lower side effects while still being effective.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Zurich, Canton of Zurich and 4 other locations) |
| Trial ID | NCT06563362 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed squamous cell carcinoma of the oropharynx who are scheduled for definitive radiotherapy.
Not a fit: Patients with pre-treatment or those with advanced disease stages may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced treatment-related toxicity for patients with oropharyngeal cancer.
How similar studies have performed: Previous studies have explored de-escalation strategies in cancer treatment, indicating potential for success, though this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / 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: 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 this trial is running
Zurich, Canton of Zurich and 4 other locations
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.