Clinical trial · Interventional
Non Elective Vulnerable Elderly Radiotherapy
NCT04832555CI-TRIAL-00051095NEVERunknownN/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)
To evaluate whether patients defined "non-fit for curative non-surgical radio-chemotherapy" and therefore treated with RT alone addressed only to non-elective sites of disease, could obtain a non-inferior loco-regional control compared to similar historical cohorts.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non elective radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open: non elective irradiation
- description
- Patients within inclusion criteria will be enrolled in the experimental treatment: a radiation therapy addressed to non elective site of disease and with a simultaneous integrated boost
- interventionNames
- Radiation: Non elective radiotherapy
Primary outcomes (1)
- measure
- Loco-regional control
- timeFrame
- 24 months after the start of treatment
- description
- clinical or radiological (RECIST 1.1) disease progression from end of treatment with tumor present, or to the date of salvage surgery of primary tumor with tumor present performed for clinical or radiological (RECIST 1.1) disease progression, whichever comes first.
Secondary outcomes (5)
- measure
- rate of severe sub-acute or late toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * locally advanced non-metastatic HNSCC patients older than 70 years * Primary tumor clinically and radiologically detectable and measurable (staging according to ed. TNM VII and also VIII. * patients defined by the tumor board (ENT, Oncologist, Radiotherapist, Nutritionist) as 1) not eligibles for RTCT / RT-cetuximab treatment 2) not amenable to radical surgery and 3) not candidates for treatments with palliative intent/best supportive care * Availability of staging with CT/PET for distant metastasis and CT/MRI for primary tumor * Karnofsky performance status (KPS) ≥60/100 * Oropharynx , Hypopharynx and Larynx, Oral cavity: stage III and IV and Unknown primitive P16-POSITIVE Exclusion Criteria: * Age less than 70 years * Staging exams done 45 days before the date of the beginning of the treatment * Subsites: nasopharynx, salivary glands, paranasal sinuses. Metastatic disease * Gross total excision * All subsites concerned if N3. * Squamous cell neoplasms of the glottic larynx T1-T2 N0. * Unknown primary HPV negative or EBV positive. * Presence of distant metastases or sub-clavicular lymphadenopathies. * Previous surgery on T and/or N except diagnostic tonsillectomy. * 3D-conformational radiotherapy technique
References
Publications (0)
Data not yet available
No reference posted for this study.