Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
Not Applicable
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Radiation: radiochemotherapy with 70 GyRadiation: radiochemotherapy with 77 Gy
- Registration Number
- NCT02352792
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard therapy radiochemotherapy with 70 Gy Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks) dose escalation radiochemotherapy with 77 Gy Standard plus 10% dose escalation to the hypoxic volume
- Primary Outcome Measures
Name Time Method time to local recurrence 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tuebingen university, radiation oncology
🇩🇪Tuebingen, Baden-Württemberg, Germany