A Study Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer
Conditions
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
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Adaptive dose-painting-by-numbers Type: Radiation
Name: standard intensity-modulated radiotherapy (IMRT) Type: Radiation
Overall Status
Recruiting
Summary
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.
Locations
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
Sponsors
University Hospital, Ghent
Source
University Hospital, Ghent
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page