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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title:

Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02352792
• Other study ID #: 2.0
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2015
• Last updated: January 30, 2015
• Start date: December 2008
• Est. completion date: December 2022

Study information

• Verified date: January 2015
• Source: University Hospital Tuebingen
• Contact: Daniel Zips, Prof. Dr. med.
• Phone: +49 7071 29 82141
• Email: daniel.zips[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2022
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Radiation:
• radiochemotherapy with 70 Gy

• radiochemotherapy with 77 Gy

Locations

Country	Name	City	State
Germany	Tuebingen university, radiation oncology	Tuebingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to local recurrence		5 years	No