Clinical trial · Interventional
Resource Sparing Curative Radiotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck: The HYPNO Trial
A Randomized Multicenter Trial of Accelerated Hypo - vs. Normo-fractionated Radiotherapy for Head and Neck Squamous Cell Carcinoma (IAEA-HYPNO Trial)
- 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 aim of the study is to test whether a resource-sparing 4-week, 20-fraction course of accelerated hypofractionated radiotherapy is non-inferior to accelerated radiotherapy delivering 33 fractions over 5.5 weeks in the treatment of patients with Stage I-IV squamous cell carcinoma of the pharynx, larynx and oral cavity with the exception of paranasal sinus, nasopharyngeal and stage I-II glottic 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 |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- 'Standard' external beam radiotherapy to deliver 66Gy in 33 fractions treating with 6 fractions a week.
- interventionNames
- Radiation: External beam radiotherapy
- type
- EXPERIMENTAL
- label
- HYPNO
- description
- The experimental regimen in which patients receive external beam radiotherapy to deliver 55Gy in 20 fractions treating 5 times a week.
- interventionNames
- Radiation: External beam radiotherapy
Primary outcomes (2)
- measure
- Primary tumor control in T and N position
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Tumor classified as stage I-IV located in oropharynx, hypopharynx, larynx (not glottic stage I-II), or oral cavity according to the TNM classification 2. Histopathological diagnosis of invasive squamous cell carcinoma at the primary site 3. Age \> 18 years 4. Informed consent according to the Helsinki declaration and local regulations 5. The patient must be a candidate for external beam radical radiotherapy, and must be expected to complete the treatment 6. WHO performance status of 0-2 7. For patients receiving concomitant chemotherapy: Normal CBC and normal function of liver and kidney by routine laboratory examinations. Impaired function of liver is defined as elevation of liver enzymes by 2.5 times the upper limit of the normal reference value for the institution and of kidney as serum creatinine by 1.5 times the upper limit of the normal reference value for the institution by routine laboratory examinations or creatinine clearance level less than 50 ml/min Exclusion Criteria 1. Distant metastases 2. The patient should not be in a state or have major co-morbidity that could be expected to influence the outcome of treatment, or interfere with the assessment of treatment outcome at follow-up, or (apart from the present disease) considerably reduce the life expectancy 3. Patients who test positive for human immunodeficiency virus (HIV) 4. Prior surgical excision (except biopsy) 5. Planned (elective) surgery 6. The existence of synchronous multiple malignancies (not leukoplakia) or previous history of cancer 7. The patient must not be pregnant 8. Socio-demographic or other factors that make it unlikely that the patient will be available for follow up of long term treatment outcome 3.5. Additional criterion for patients receiving chemotherapy
References
Publications (0)
Data not yet available