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

NCT02352792 | Unknown

• 1 other identifier: 2.0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Local control

Outcome Measures

Primary Outcomes (1)

• time to local recurrence

  5 years

Study Arms (2)

Standard therapy

ACTIVE COMPARATOR

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

dose escalation

EXPERIMENTAL

Standard plus 10% dose escalation to the hypoxic volume

Radiation: radiochemotherapy with 77 Gy

Interventions

radiochemotherapy with 70 Gy RADIATION

Standard therapy

radiochemotherapy with 77 Gy RADIATION

dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• uncontrolled secondary cancer
• distant metastases
• pregnancy
• expected malcompliance

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Tuebingen university, radiation oncology

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Stefan Welz, Dr. med.

  radiation oncology

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: December 1, 2008
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2022
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

DE (1)