Clinical trial · Interventional
Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging
Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging: Multi-center, Randomized Phase-II-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 trial evaluates the value of radiation dose escalation based on Hypoxia detection by 18F\_misonidazole Positron Emission Tomography (18F-MISO-PET) for primary radiochemotherapy of head and neck squamous cell carcinoma. Patients negative for human papillomavirus (HPV) and with hypoxic tumours after 2 weeks of radiochemotherapy are randomized to completion of standard radiochemotherapy or radiochemotherapy with escalated radiation dose. An additional interventional arm includes a carbon ion boost. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dose-escalated radiochemotherapy | Radiation | — | UNRESOLVED |
| dose-escalated radiochemotherapy with carbon ion boost | Radiation | — | UNRESOLVED |
| standard radiochemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- OTHER
- label
- standard radiochemotherapy, hypoxic
- description
- HPV (-), hypoxic in 18F-MISO PET after 2 weeks of radiochemotherapy, randomized to standard radiation dose, 70 Gy standard radiochemotherapy
- interventionNames
- Radiation: standard radiochemotherapy
- type
- EXPERIMENTAL
- label
- dose-escalated radiochemotherapy, hypoxic
- description
- HPV (-), hypoxic in 18F-MISO PET after 2 weeks of radiochemotherapy, randomized to escalated radiation dose, 77 Gy radiochemotherapy
- interventionNames
- Radiation: dose-escalated radiochemotherapy
- type
- EXPERIMENTAL
- label
- escalated radiochemoth., carbon boost, hypoxic
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: older than 18 years * WHO (ECOG) performance status 0-2 * Histological proven HNSCC * HPV negative tumors or HPV positive tumors * Stage III, IVA or IVB HNSCC according to UICC and AJCC guidelines * Tumor classified as irresectable or patient inoperable or patient refused surgery * Tumor extension and localization suitable for radiochemotherapy with curative intent * Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications) * Dental examination and -treatment before start of therapy * For women with childbearing potential and men in reproductive ages adequate contraception. * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * Refusal of the patients to take part in the trial * Presence of distant metastases (UICC stage IVC) * Previous radiotherapy in the head and neck region * Second malignancy that is likely to require treatment during the trial intervention or follow-up period or that, in the opinion of the physician, has a considerable risk of recurrence or metastases within the follow-up period * Serious disease or medical condition with life expectancy of less than one year * Participation in competing interventional trial on cancer treatment * Patients who are not suitable for radiochemotherapy * Pregnant or lactating women * Patients not able to understand the character and individual consequences of the trial * Nasopharyngeal Carcinomas
References
Publications (0)
Data not yet available