Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.

Phase 2

Completed

• Conditions: Primary Non-operated Squamous Cell Carcinoma of Oropharynx; Primary Non-operated Squamous Cell Carcinoma of Hypopharynx; Primary Non-operated Squamous Cell Carcinoma of Oral Cavity; Primary Non-operated Squamous Cell Carcinoma of Larynx
• Interventions: Radiation: standard intensity-modulated radiotherapy (IMRT); Radiation: Adaptive dose-painting-by-numbers

• Registration Number: NCT01341535
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-25
• Study Start: 2011-09
• Primary Completion: 2017-10-31
• Study Completion: 2021-07-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard IMRT	standard intensity-modulated radiotherapy (IMRT)	This patient group will be treated by standard intensity-modulated radiotherapy (IMRT), while patients in the experimental arm will receive adaptive dose-painting-by-numbers. Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.
adaptive DPBN	Adaptive dose-painting-by-numbers	This patient group will be treated by adaptive dose-painting-by-numbers, while patients in the control arm will receive standard treatment. Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.

Primary Outcome Measures

Name	Time	Method
To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.	at 1 year	18F-FDG-PET/CT scans will be performed.

Secondary Outcome Measures

Name	Time	Method
Acute toxicity	up to 12 months of follow-up
Topography of local and/or regional relapse.	during the first year post-treatment	18F-FDG-PET/CT scans will be performed during the first year post-treatment time point of local and/or regional relapse
Time point of local and/or regional relapse.	during the first year post-treatment	18F-FDG-PET/CT scans will be performed.
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	18F-FDG-PET/CT scans will be performed.
Tumor response	3 months post-treatment	18F-FDG-PET/CT scans will be performed

Trial Locations

Locations (2)

Department of Radiotherapy, University Hospital Ghent; 🇧🇪 Ghent, Belgium

Clinique & Materinité Sainte Elisabeth; 🇧🇪 Namur, Belgium