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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02352792

Enrollment

Registered

2015-02-02

Start date

2008-12-31

Completion date

2022-12-31

Last updated

2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Local control

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).

Interventions

RADIATIONradiochemotherapy with 70 Gy

RADIATIONradiochemotherapy with 77 Gy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
time to local recurrence	5 years

Countries

Germany

Contacts

Primary ContactDaniel Zips, Prof. Dr. med.

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

Backup ContactSilke Theden, Mrs.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026