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

University Hospital Tuebingen90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

radiochemotherapy with 70 GyRADIATION

radiochemotherapy with 77 GyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tuebingen university, radiation oncology

Tübingen, Baden-Wurttemberg, Germany

RECRUITING

Outcomes

Primary Outcomes

time to local recurrence

Time frame: 5 years

Central Contacts

Daniel Zips, Prof. Dr. med.

CONTACT

+49 7071 29 82141 daniel.zips@med.uni-tuebingen.de

Silke Theden, Mrs.

CONTACT

+49 7071 29 83420 silke.theden@med-uni-tuebingen.de

Data from ClinicalTrials.gov

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