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

NCT06563362 | Recruiting Phase 2

• 1 other identifier: DeEscO
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

Multicentric prospective model-based de-escalation of the elective clinical target volumes (CTV) in radiotherapy of oropharyngeal carcinoma of all stages with the goal to reduce toxicity. The study investigates the feasibility of this approach as measured by the number of expected out-of-field recurrencies based on the individual patient's state of disease progression and risk factors

Conditions

Oropharynx Cancer

Keywords

head and neck cancer; radiotherapy; elective CTV; clinical target volume; de-escalation

Outcome Measures

Primary Outcomes (1)

• out-of field nodal recurrence rate at 2 years

  efficacy of personalized CTV-N reduction in oropharyngeal SCC patients 2 years after the end of the primary (chemo)radiotherapy treatment measured by the Kaplan-Meier estimator for the cumulative probability of out-of-field N-site recurrences (incidence of lymph node metastases in non-irradiated LNLs).

  from completion of treatment up to 2 years after radiotherapy

Secondary Outcomes (17)

• out-of field nodal recurrence rate at 3 years

  from completion of treatment up to 3 years after radiotherapy

• Loco-regional control (LCR) rate at 2 years

  from completion of treatment up to 2 years after radiotherapy

• Loco-regional control (LCR) rate at 3 years

  from completion of treatment up to 3 years after radiotherapy

• Progression-free survival (PFS) at 2 years

  from completion of treatment up to 2 years after radiotherapy

• Progression-free survival (PFS) at 3 years

  from completion of treatment up to 3 years after radiotherapy

Other Outcomes (1)

• Assessement of values and longitudinal changes in total blood count, including lymphocytes (explorative assessement)

  Treatment start and every 3 months up to 3 years after radiotherapy

Study Arms (1)

Elective target volume de-escalation arm

EXPERIMENTAL

Target volume de-escalation

Radiation: De-escalation of irradiated volume

Interventions

De-escalation of irradiated volume RADIATION

De-escalation of elective clinical target volumes as recommended by a model-based approach

Elective target volume de-escalation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants need to provide informed consent.

You may not qualify if:

• 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.
• Participants need to provide informed consent.
• 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.

Sponsors & Collaborators

• University of Zurich: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Geneva: collaborator
• Ospedale Regionale Bellinzona e Valli: collaborator
• Réseau Hospitalier Neuchâtelois: collaborator
• Kantonsspital Aarau: collaborator

Study Sites (5)

Zurich University Hospital

Zurich, Canton of Zurich, 8091, 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

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Panagiotis Balermpas, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panagiotis Balermpas, MD

CONTACT

+41 44 255 35 67; Panagiotis.Balermpas@usz.ch

Debra Lauer, MSc

CONTACT

+41 43 253 28 17; RAO_Akademischesoffice@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 20, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)