An interventional study of external beam proton radiation therapy. in Epithelial Tumor, Malignant and Neuroendocrine Tumors, sponsored by CNAO National Center of Oncological Hadrontherapy. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by CNAO National Center of Oncological Hadrontherapy · Not applicable, Interventional, and Treatment
The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →CNAO National Center of Oncological Hadrontherapy is the lead sponsor of 11 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A total of 20 patients will be irradiated with protons after photon IMRT
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.
Local response
RECIST criteria
Time frame: 90 days
Acute toxicity
According to CTCAE v4.0
Time frame: 90 days
Local control
RECIST criteria on MRI evaluation
Time frame: 5 years
Disease free survival
RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse
Time frame: 5 years
Overall survival
On MRI and total body CT evaluation - months from RT treatment to death
Time frame: 5 years
Late toxicity
According to CTCAE v4.0 registered during follow up visits
Time frame: 5 years
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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CNAO National Center of Oncological Hadrontherapy