Clinical trial · Interventional
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
- 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)
Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiochemotherapy with 70 Gy | Radiation | — | UNRESOLVED |
| radiochemotherapy with 77 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard therapy
- description
- Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)
- interventionNames
- Radiation: radiochemotherapy with 70 Gy
- type
- EXPERIMENTAL
- label
- dose escalation
- description
- Standard plus 10% dose escalation to the hypoxic volume
- interventionNames
- Radiation: radiochemotherapy with 77 Gy
Primary outcomes (1)
- measure
- time to local recurrence
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy * measurabel disease by CT and/or MRT and/or FDG-PET-CT * fit for chemotherapy * no prior radiotherapy or major surgery in the head/neck region * Karnofsky Index \> 60% * informed consent Exclusion Criteria: * uncontrolled secondary cancer * distant metastases * pregnancy * expected malcompliance
References
Publications (0)
Data not yet available