Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HNSCC receiving (chemo)radiotherapy<br>Imaging | Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| relative response will be calculated for the decrease of the SUV-value | the prognostic value of the FDG-PET/CT-scans | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adaptive, Image-guided, Radiotherapy, Head and Neck cancer