Clinical trial · Interventional
Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma
A Non-Randomized, Open-Label, Multi-Center Pilot Study Evaluating Hypofractionation Radiation Therapy in Head and Neck Squamous Cell Carcinoma
- 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)
The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers in patients 70 years of age and older. Standard radiation treatment for head and neck patients normally requires that the patient travel to the hospital daily for 6-7 weeks to receive radiation treatment 5 days per week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. If this happens, and there are gaps in the radiation treatment, this can lead to worse outcomes.
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 Squamous Cell Carcinoma (HNSCC) | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant hypofractionation | Radiation | — | UNRESOLVED |
| Definitive Hypofractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant Hypofractionated Radiation Treatment
- description
- Short course radiation therapy for patients who have undergone surgery
- interventionNames
- Radiation: Adjuvant hypofractionation
- type
- EXPERIMENTAL
- label
- Definitive Hypofractionated Radiation Treatment
- description
- Short course radiation therapy for patients who have not had surgery
- interventionNames
- Radiation: Definitive Hypofractionation
Primary outcomes (1)
- measure
- Number of participants with Locoregional Control (LRC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria * Age ≥ 70 years. * No previous RT or chemotherapy for HNSCC is allowed at time of study entry. * Life expectancy \> 12 weeks. * Participants must have histologically or cytologically confirmed diagnosis of HNSCC: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary) * All stages (according to National Comprehensive Cancer Network 8th edition for head and neck cancers), except stage IVC5 * Non-concurrent chemotherapy * First line treatment * Anyone eligible for definitive or adjuvant based RT therapy * Adjuvant therapy when histopathological factors (advanced T category, nodal disease, lymphovascular or perineural invasion, high-grade, or positive margins) * Anyone being treated with curative intent * Unfit as determined by the treating physician and ECOG performance 1, 2, or 3 (Appendix 2). * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria * Patients \< 70 * Metastatic disease outside of the head and neck * Pregnancy * Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years. * Prior RT of head and neck area * Concurrent chemotherapy or immunotherapy or hormonotherapy * Any comorbid connective tissue disorder which could aggravate RT associated toxicities (e.g. Scleroderma) * In cases where patients cannot consent on their own due to underlying dementia, we can consent the patient's healthcare proxy
References
Publications (0)
Data not yet available