Proton Boost for Locally Advanced HEAD AND NECK TUMORS
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ClinicalTrials.gov Identifier: NCT03183271 |
Recruitment Status
:
Completed
First Posted
: June 12, 2017
Last Update Posted
: June 14, 2017
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Condition or disease | Intervention/treatment | Phase |
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Epithelial Tumor, Malignant Neuroendocrine Tumors | Radiation: external beam proton radiation therapy. | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS |
Actual Study Start Date : | July 16, 2012 |
Actual Primary Completion Date : | March 30, 2015 |
Actual Study Completion Date : | September 30, 2016 |
Arm | Intervention/treatment |
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Experimental: Experimental: External beam radiotherapy
A total of 20 patients will be irradiated with protons after photon IMRT
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Radiation: 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.
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- Local response [ Time Frame: 90 days ]RECIST criteria
- Acute toxicity [ Time Frame: 90 days ]According to CTCAE v4.0
- Local control [ Time Frame: 5 years ]RECIST criteria on MRI evaluation
- Disease free survival [ Time Frame: 5 years ]RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse
- Overall survival [ Time Frame: 5 years ]On MRI and total body CT evaluation - months from RT treatment to death
- Late toxicity [ Time Frame: 5 years ]According to CTCAE v4.0 registered during follow up visits

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183271
Italy | |
CNAO | |
Pavia, Italy, 27100 |
Responsible Party: | CNAO National Center of Oncological Hadrontherapy |
ClinicalTrials.gov Identifier: | NCT03183271 History of Changes |
Other Study ID Numbers: |
CNAO 06/2011 |
First Posted: | June 12, 2017 Key Record Dates |
Last Update Posted: | June 14, 2017 |
Last Verified: | June 2017 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Neoplasms Neuroendocrine Tumors Head and Neck Neoplasms Carcinoma Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms by Site Neoplasms, Glandular and Epithelial |