Clinical trial · Interventional
Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Non-operated Squamous Cell Carcinoma of Hypopharynx | — | UNRESOLVED | — |
| Primary Non-operated Squamous Cell Carcinoma of Larynx | — | UNRESOLVED | — |
| Primary Non-operated Squamous Cell Carcinoma of Oral Cavity | — | UNRESOLVED | — |
| Primary Non-operated Squamous Cell Carcinoma of Oropharynx | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive dose-painting-by-numbers | Radiation | — | UNRESOLVED |
| standard intensity-modulated radiotherapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- adaptive DPBN
- description
- 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.
- interventionNames
- Radiation: Adaptive dose-painting-by-numbers
- type
- ACTIVE_COMPARATOR
- label
- standard IMRT
- description
- 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.
- interventionNames
- Radiation: standard intensity-modulated radiotherapy (IMRT)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDe 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. PMID 38387811