Clinical trial · Interventional
Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma
NCT05650034CI-TRIAL-00062672unknownN/AClinicalTrials.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)
This is a non-randomized prospective trial evaluating the non- inferiority of de-escalating the volume and/or dose of elective nodal irradiation in post-operative head and neck squamous cell carcinomas.
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 |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elective nodal de-escalation arm | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Elective nodal de-escalation arm
- description
- Omission of elective nodal irradiation in N0 hemi-neck of well lateralized H\&N SCCs ( pN0 or by PETCT). Dose de-escalation of elective nodal irradiation in N0 hemi-neck of midline H\&N SCCs ( pN0 or by PETCT).
- interventionNames
- Radiation: Elective nodal de-escalation arm
Primary outcomes (1)
- measure
- Regional failure in the omitted/de-escalated elective nodal irradiation site
- timeFrame
- Baseline to 1 year
Secondary outcomes (3)
- measure
- Acute toxicity
- timeFrame
- Baseline to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a Karnofsky performance score of 70% or more. * Completely or partially resected head and neck SCC. This includes: The oral cavity (lips, buccal mucosa, oral tongue, floor of mouth, gingiva, retromolar trigone, and hard palate), maxilla, oropharynx, and larynx. * Patients with at least an ipsilateral neck dissection. * Patient has at least one pathological feature that is an indication for PORT: positive or close (\<5 mm) margin, presence of LVI or PNI, pT3 or pT4 disease, positive lymph nodes, or ENE. * Pathologically lymph node negative in at least one dissected hemi-neck or PET-CT Exclusion Criteria: * Patients with bilaterally involved neck nodes * Patients with pT3-T4 tumors involving midline who undergo an ipsilateral neck dissection (unless a contralateral neck dissection is performed) * Serious medical comorbidities or other contraindications to radiotherapy * Prior history of head and neck cancer within 5 years * Any other active invasive malignancy * Prior head and neck radiation at any time * Prior oncologic head and neck surgery in the oral cavity or neck. * Known metastatic disease * Locoregional disease recurrence identified following surgical resection but prior to start of radiotherapy * Inability to attend full course of radiotherapy or follow-up visits 11.Unable or unwilling to complete QoL questionnaires
References
Publications (0)
Data not yet available
No reference posted for this study.