Clinical trial · Interventional
IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck
IAEA-HypoX. A Randomized Multicenter Study of Accelerated Fractionated Radiotherapy With or Without the Hypoxic Radiosensitizer Nimorazole in the Treatment of Squamous Cell Carcinoma of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient recruitment
Summary
Brief summary (as posted)
The purpose of this study is to test the hypothesis that radiotherapy of head and neck carcinoma can be improved by hypoxic modification of radiotherapy using nimorazole as a hypoxic radiosensitizer in association with accelerated fractionation, in an unselected patient population in a global environment.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accl. radiotherapy + Nimorazole | Radiation | — | UNRESOLVED |
| Accl. RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Accl. RT
- description
- Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
- interventionNames
- Radiation: Accl. RT
- type
- EXPERIMENTAL
- label
- Accl. RT + Nimorazole
- description
- Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole
- interventionNames
- Radiation: Accl. RT
- Radiation: Accl. radiotherapy + Nimorazole
Primary outcomes (1)
- measure
- Locoregional control after curative intended radiotherapy +/- Nimorazole
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor classified as stage I-IV located in oropharynx, hypopharynx, larynx (not glottic stage I-II), or oral cavity according to the TNM classification. * Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumor. * Informed consent according to the Helsinki declaration and local regula-tions. * The patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment. * Performance status 0-2 according to WHO criteria. * The patient should not have symptoms of peripheral neuropathy assessed by clinical examination. * Normal function of liver and kidney by routine laboratory examinations. The patient must not be pregnant Exclusion Criteria: * Distant metastases. * The patient should not be in a state or condition that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy. * Surgical excision (except biopsy), prior or planned (including elective neck dissection). * The existence of synchronous multiple malignancies (not leukoplakia).
References
Publications (0)
Data not yet available