Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx

Study Overview
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Brief Summary
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Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.

Detailed Description
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The objective is to assess the feasibility (i.e. early toxicity) of an adaptive dose escalation through 18F-FDG-PET-based dose painting by numbers in 10 HPV negative patients with locally advanced squamous cell carcinoma of the oropharynx. Treatment will be delivered with Helical Tomotherapy® or volumetric-modulated arc therapy (VMAT). Dose adaptation will be performed at 2 time-points with per-treatment 18F-FDG-PET/CT scans.

Official Title
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Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced Squamous Cell Carcinoma of the Oropharynx: a Phase-I Study.

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: dose escalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Patients with squamous cell carcinoma of the oropharynx, HPV-negative (p16 assay) T size of 3 cm or more in greatest dimension with the exclusion of tumor with bone infiltration N0, N1, N2a, N2b node (AJCC/UICC 7th edition) No distant metastasis No contra-indication to concomitant chemotherapy World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥ 80. Provision of written informed consent Exclusion Criteria: Patients with induction chemotherapy will not be eligible Previous or concurrent history of cancer, except basal cell skin carcinoma Second primary tumor at the time of diagnosis Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder Pregnant or lactating women

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation<br>Dose escalation | Radiation: dose escalation<br>* molecular imaging based radiotherapy dose escalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity |  | up to 3 months following the completion of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary tumor control probability |  | at 1 and 2 years | 
| Late toxicity |  | at 1 and 2 years | 
| Progression-free survival |  | at 1 and 2 years | 
| Overall survival |  | at 1 and 2 years |