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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT02352792

Collaborator

(none)

Enrollment

Location

Arms

168

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of the Head and Neck	Radiation: radiochemotherapy with 70 Gy Radiation: radiochemotherapy with 77 Gy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)	Radiation: radiochemotherapy with 70 Gy
Experimental: dose escalation Standard plus 10% dose escalation to the hypoxic volume	Radiation: radiochemotherapy with 77 Gy

Arm

Intervention/Treatment

Active Comparator: 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)

Radiation: radiochemotherapy with 70 Gy

Experimental: dose escalation

Standard plus 10% dose escalation to the hypoxic volume

Radiation: radiochemotherapy with 77 Gy

Outcome Measures

Primary Outcome Measures

time to local recurrence [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tuebingen university, radiation oncology	Tuebingen	Baden-Württemberg	Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator: Stefan Welz, Dr. med., radiation oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT02352792

Other Study ID Numbers:

First Posted:

Feb 2, 2015

Last Update Posted:

Feb 2, 2015

Last Verified:

Jan 1, 2015

Keywords provided by University Hospital Tuebingen

Local control

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Feb 2, 2015