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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adaptive DPBN | Experimental | 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. |
|
| standard IMRT | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive dose-painting-by-numbers | Radiation | Adaptive dose escalation by dose-painting-by-numbers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment. | 18F-FDG-PET/CT scans will be performed. | at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Regional (elective neck) and distant control. | 18F-FDG-PET/CT scans will be performed. | after 1 year |
| Topography of local and/or regional relapse. | 18F-FDG-PET/CT scans will be performed during the first year post-treatment time point of local and/or regional relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Neve, Ph.D., M.D. | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiotherapy, University Hospital Ghent | Ghent | 9000 | Belgium | |||
| Clinique & Materinité Sainte Elisabeth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38387811 | Derived | De Bruycker A, De Neve W, Daisne JF, Vercauteren T, De Gersem W, Olteanu L, Berwouts D, Deheneffe S, Madani I, Goethals I, Duprez F. Disease Control and Late Toxicity in Adaptive Dose Painting by Numbers Versus Nonadaptive Radiation Therapy for Head and Neck Cancer: A Randomized Controlled Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2024 Oct 1;120(2):516-527. doi: 10.1016/j.ijrobp.2024.01.012. Epub 2024 Feb 21. |
| Label | URL |
|---|---|
| Related Info | View source |
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| standard intensity-modulated radiotherapy (IMRT) | Radiation | Standard radiotherapy for head and neck cancer. |
|
| during the first year post-treatment |
| Tumor response | 18F-FDG-PET/CT scans will be performed | 3 months 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 |
| Time point of local and/or regional relapse. | 18F-FDG-PET/CT scans will be performed. | during the first year post-treatment |
| Namur |
| Belgium |