Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer

University Hospital Tuebingen

Status: Unknown

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Radiation: radiochemotherapy with 70 Gy; Radiation: radiochemotherapy with 77 Gy

Study type: Interventional

Funder types: Other

Identifiers

NCT02352792

2.0

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Standard therapy

Active Comparator group

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)

Treatment:

Radiation: radiochemotherapy with 70 Gy

dose escalation

Experimental group

Description:

Standard plus 10% dose escalation to the hypoxic volume

Treatment:

Radiation: radiochemotherapy with 77 Gy