Clinical trial · Interventional
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck
NCT06563362CI-TRIAL-00123233DeEscOrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| De-escalation of irradiated volume | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Elective target volume de-escalation arm
- description
- Target volume de-escalation
- interventionNames
- Radiation: De-escalation of irradiated volume
Primary outcomes (1)
- measure
- out-of field nodal recurrence rate at 2 years
- timeFrame
- from completion of treatment up to 2 years after radiotherapy
- description
- 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).
Secondary outcomes (17)
- measure
- out-of field nodal recurrence rate at 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLooman EL, Perez Haas Y, Ludwig R, Lauer D, Morand GB, Guckenberger M, Elicin O, Giger R, Tran S, Martucci F, Melab-Belkhodja S, Riesterer O, Benke-Bruderer S, Unkelbach J, Balermpas P. Personalized volume de-escalated elective nodal irradiation in oropharyngeal squamous cell carcinoma (DeEscO): a study protocol. Clin Transl Radiat Oncol. 2026 May 12;59:101182. doi: 10.1016/j.ctro.2026.101182. eCollection 2026 Jul. PMID 42200110