Clinical trial NCT01341535: Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.
Official title: A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Non-operated Squamous Cell Carcinoma of Oral Cavity
Primary Non-operated Squamous Cell Carcinoma of Oropharynx
Primary Non-operated Squamous Cell Carcinoma of Hypopharynx
Primary Non-operated Squamous Cell Carcinoma of Larynx
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.


Eligibility 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.

Primary outcomes:
measure: To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.
timeFrame: at 1 year
Secondary outcomes:
measure: Regional (elective neck) and distant control.
timeFrame: after 1 year
measure: Topography of local and/or regional relapse.
timeFrame: during the first year post-treatment
measure: Tumor response
timeFrame: 3 months post-treatment
measure: Acute toxicity
timeFrame: up to 12 months of follow-up
measure: Overall disease-specific, disease-free survival.
timeFrame: at 1 year
measure: Late toxicity
timeFrame: up to 12 months of follow-up
measure: Time point of local and/or regional relapse.
timeFrame: during the first year post-treatment
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Radiotherapy, University Hospital Ghent
city: Namur
country: Belgium
facility: Clinique & Materinité Sainte Elisabeth
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: