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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.
If there is a complete metabolic response on the FDG-PET after 2 weeks, the entire tumor will receive 70 Gy. If there is a complete metabolic response after 4 weeks of treatment, the residual FDG-avid area will receive 74 Gy. If there also is no complete metabolic response after 4 weeks of treatment, the residual FDG-avid area will receive 78 Gy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HNSCC receiving (chemo)radiotherapy | Other | Imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive dose-Escalated multi-modality image-guided radiotherapy | Radiation | FDG-PET/CT-scan will be used twice during radiotherapy for a mild dose-escalation to the less-responding parts of the tumor. By adapting the radiotherapy plan, these areas will receive 74-78 Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| the feasibility of the adaptive radiotherapy scheme estimated by the acute toxicities and implementation of the adaptive treatment plans | The feasibility of the adaptive radiotherapy schedule will be rejected in case of: Occurrence of intolerable radiation-induced acute toxicities. | 1 year |
| the feasibility of the adaptive radiotherapy scheme estimated by the implementation of the adaptive treatment plans | The feasibility of the adaptive radiotherapy schedule will be rejected in case of: The inability to implement 80% of the adaptive treatment plans within 2 days from the intended starting day | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| the toxicity of the adaptive RT scheme | according to the CTCAE v4.0 scoring system | 1 year |
| the locoregional tumor control | 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abrahim Al-Mamgani, MD, PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | 1066CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37753461 | Derived | Al-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. | |
| 32361007 |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Feasibility study
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| relative response will be calculated for the decrease of the SUV-value |
the prognostic value of the FDG-PET/CT-scans |
| 1 year |
| Gouw 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. |