A Study Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer
Primary Non-operated Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx and Larynx.
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Adaptive dose-painting-by-numbers Type: Radiation
Name: standard intensity-modulated radiotherapy (IMRT) Type: Radiation
Overall Status
The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-FDG-PET/CT scans to adaptive 18F-FDG-PET-voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-FDG-PET/CT scans for head and neck cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx

- Primary unresectable tumor and/or patients that refused surgery

- Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer

- Multidisciplinary decision of curative radiotherapy or radiochemotherapy

- Karnofsky performance status >= 70 %

- Age >= 18 years old

- Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

- High risk Human Papilloma Virus (HPV)

- Treatment combined with brachytherapy

- Prior irradiation to the head and neck region

- History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.

- Distant metastases

- Pregnant or lactating women

- Creatinine clearance (Cockcroft-Gault) =< 60 mL/min

- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study

- Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Department of Radiotherapy, University Hospital Ghent
Ghent, Belgium
Status: Recruiting
Contact: Wilfried De Neve, Ph.D., M.D. - Wilfried.Deneve@ugent.be
Clinique & Materinité Sainte Elisabeth
Namen, Belgium
Status: Recruiting
Contact: Jean-François Daisne, MD
Start Date
September 2011
Completion Date
December 2015
University Hospital, Ghent
University Hospital, Ghent
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page