Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2012-07-16
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: External beam radiotherapy
A total of 20 patients will be irradiated with protons after photon IMRT
external beam proton radiation therapy.
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.
Interventions
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external beam proton radiation therapy.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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CNAO National Center of Oncological Hadrontherapy
OTHER
Responsible Party
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Locations
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CNAO
Pavia, , Italy
Countries
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Other Identifiers
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CNAO 06/2011
Identifier Type: -
Identifier Source: org_study_id
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