Clinical trial · Interventional
Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy
Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy (ADMIRE) for Head and Neck Cancer by Twice Re-imaging, Re-delineation and Re-planning During the Course of Radiotherapy
- 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)
Patients with primary head and neck squamous cell carcinoma (HNSCC) planned for treatment with radiotherapy with or without chemotherapy in curative setting will be treated with an adaptive radiotherapy scheme. An FDG-PET/CT scan for re-delineation and re-planning will be made at the end of the second and fourth of week of radiotherapy. The non-responding part of the tumor on FDG-PET will receive a mild dose-escalation. Depending on the metabolic response, the entire tumor will receive 70 Gy or the residual FDG-avid area will receive 74 or 78 Gy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive dose-Escalated multi-modality image-guided radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- HNSCC receiving (chemo)radiotherapy
- description
- Imaging
- interventionNames
- Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy
Primary outcomes (2)
- measure
- the feasibility of the adaptive radiotherapy scheme estimated by the acute toxicities and implementation of the adaptive treatment plans
- timeFrame
- 1 year
- description
- The feasibility of the adaptive radiotherapy schedule will be rejected in case of: Occurrence of intolerable radiation-induced acute toxicities.
- measure
- the feasibility of the adaptive radiotherapy scheme estimated by the implementation of the adaptive treatment plans
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic biopsy confirmed squamous cell carcinoma of the oral cavity, HPV-negative oropharynx, HPV-positive oropharynx with a minimum of 10 pack-years, hypopharynx or larynx * T2-T4 * Scheduled for radiotherapy or radiotherapy with cisplatin or cetuximab Exclusion Criteria: * GFR\<30 * Other neoplasms with metastases in the previous 3 years
References
Publications (2)
- DERIVEDAl-Mamgani A, Kessels R, Gouw ZAR, Navran A, Mohan V, van de Kamer JB, Sonke JJ, Vogel WV. Adaptive FDG-PET/CT guided dose escalation in head and neck squamous cell carcinoma: Late toxicity and oncologic outcomes (The ADMIRE study). Clin Transl Radiat Oncol. 2023 Sep 17;43:100676. doi: 10.1016/j.ctro.2023.100676. eCollection 2023 Nov. PMID 37753461
- DERIVEDGouw ZAR, La Fontaine MD, Vogel WV, van de Kamer JB, Sonke JJ, Al-Mamgani A. Single-Center Prospective Trial Investigating the Feasibility of Serial FDG-PET Guided Adaptive Radiation Therapy for Head and Neck Cancer. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):960-968. doi: 10.1016/j.ijrobp.2020.04.030. Epub 2020 Apr 30. PMID 32361007