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.

University Hospital, Ghent2 sites in 1 country100 target enrollmentSeptember 2011

ConditionsPrimary 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

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Primary Non-operated Squamous Cell Carcinoma of Oral Cavity
Sponsor: University Hospital, Ghent
Enrollment: 100
Locations: 2
Primary Endpoint: To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

July 15, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.

Time Frame: at 1 year

18F-FDG-PET/CT scans will be performed.

Secondary Outcomes

Topography of local and/or regional relapse.(during the first year post-treatment)
Time point of local and/or regional relapse.(during the first year post-treatment)
Acute toxicity(up to 12 months of follow-up)
Overall disease-specific, disease-free survival.(at 1 year)
Late toxicity(up to 12 months of follow-up)
Regional (elective neck) and distant control.(after 1 year)
Tumor response(3 months post-treatment)