NCT03183271

Proton Boost for Locally Advanced HEAD AND NECK TUMORS

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: CNAO National Center of Oncological Hadrontherapy · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Epithelial Tumor, Malignant
• Neuroendocrine Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-07-16
• Primary completion: 2015-03-30
• Completion: 2016-09-30
• First posted: 2017-06-12
• Last updated: 2017-06-14

Locations

1 site across 1 country: Italy