Proton Boost for Locally Advanced HEAD AND NECK TUMORS

Study Overview
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Brief Summary
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The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).

Detailed Description
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Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy [RBE] in 2-3 Gy [RBE] per fractions for 8-15 total fractions. PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up to a total dose of 50-60 Gy [RBE]. Secondary endpoints of the trial are local control, relapse free survival, overall survival, tumor specific survival, intermediate and long term toxicity.

Official Title
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Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS

Conditions
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Epithelial Tumor, Malignant, Neuroendocrine Tumors

Intervention / Treatment
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* Radiation: external beam proton radiation therapy.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic/cytologic diagnosis of primary epithelial malignant or neuroendocrine tumour Inoperable tumour, locally advanced stage Seated in rhinopharynx, nasal and paranasal sinuses, hypopharynx, larynx, oral cavity and oropharynx At least one lesion measured according to the RECIST criteria Enrollment for irradiation with IMRT up to 50-60 Gy RBE] on the PTV1rx and PTV2 rx to be followed at CNAO with irradiation with proton boost on thePTV1rx. Exclusion Criteria: Metastasis Previous radiotherapy Any metallic implants or other conditions such to prevent an adequate imaging of target volume Unavailability of previous IMRT first phase radiotherapy plans

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Experimental: External beam radiotherapy<br>A total of 20 patients will be irradiated with protons after photon IMRT | Radiation: external beam proton radiation therapy.<br>* Treatment of irradiation with protons beam The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, or at referral Hospitals enrolling head and neck patients for treatment with photon IMRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local response | RECIST criteria | 90 days | 
| Acute toxicity | According to CTCAE v4.0 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | RECIST criteria on MRI evaluation | 5 years | 
| Disease free survival | RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse | 5 years | 
| Overall survival | On MRI and total body CT evaluation - months from RT treatment to death | 5 years | 
| Late toxicity | According to CTCAE v4.0 registered during follow up visits | 5 years |