Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- time to local recurrence
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard therapy
Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)
Intervention: radiochemotherapy with 70 Gy (Radiation)
dose escalation
Standard plus 10% dose escalation to the hypoxic volume
Intervention: radiochemotherapy with 77 Gy (Radiation)
Outcomes
Primary Outcomes
time to local recurrence
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported