Clinical trial · Interventional
Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC
Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable 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)
Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.
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 | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated RT | Radiation | — | UNRESOLVED |
| Standard RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard RT
- description
- 70 Gy / 7 weeks / 2 Gy per fraction
- interventionNames
- Radiation: Standard RT
- type
- EXPERIMENTAL
- label
- Hypofractionated RT
- description
- 55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy
- interventionNames
- Radiation: Hypofractionated RT
Primary outcomes (1)
- measure
- Locoregional control
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 70 or over * SIOG group 2 (vulnerable) * Life expectancy \> 12 weeks * PS \< 2 * Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary). * First line treatment * At least one measurable lesion (RECIST) * Stage II to IV * Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized * Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area * Consent form signed Exclusion Criteria: * Primary squamous cell carcinoma of sinus, the skin or of the salivary glands * Stage I cancer * Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy * Prior radiotherapy of head and neck area * Concurrent chemotherapy or immunotherapy or hormonotherapy * Induction chemotherapy * Concomitant infection requiring IV antibiotics * cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted) * conditions that could lead to bad compliance
References
Publications (1)
- DERIVEDOrtholan C, Auperin A, Tao Y, Renard S, Pointreau Y, Lafond C, Bera G, Boisselier P, Benezery K, Racadot S, Huguet F, Bollet M, Braccini AL, Khoury C, Jacquot S, Villa J, Martin L, Di Rito A, Wiazzane N, Goineau A, Dupin C, Cartier L, Ruffier A, Cheurfa N, Schwob D, Mertens C, Le Caer H, Bourhis J, Guigay J, Sun XS; ELAN Group including Gustave Roussy, Unicancer GERICO and the H&N groups, and the GORTEC. Hypofractionated split-course versus standard radiotherapy in frail older patients with head and neck squamous-cell carcinoma (ELAN-RT trial): a non-inferiority, multicentre, open-label, randomised controlled trial. Lancet Healthy Longev. 2026 Jan;7(1):100812. doi: 10.1016/j.lanhl.2025.100812. Epub 2026 Feb 16. PMID 41713468