An interventional study of Adaptive dose-Escalated multi-modality image-guided radiotherapy in Head and Neck Cancer, sponsored by The Netherlands Cancer Institute. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-27.
Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Imaging
Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy
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.
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.
Time frame: 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
Time frame: 1 year
the toxicity of the adaptive RT scheme
according to the CTCAE v4.0 scoring system
Time frame: 1 year
the locoregional tumor control
Time frame: 1 year
relative response will be calculated for the decrease of the SUV-value
the prognostic value of the FDG-PET/CT-scans
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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The Netherlands Cancer Institute