Proton Boost for Locally Advanced HEAD AND NECK TUMORS

Not Applicable

Completed

• Conditions: Epithelial Tumor, Malignant; Neuroendocrine Tumors
• Interventions: Radiation: external beam proton radiation therapy.

• Registration Number: NCT03183271
• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy

Brief 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.

Study Timeline

• Study Start: 2012-07-16
• Primary Completion: 2015-03-30
• Study Completion: 2016-09-30
• Status Verified: 2017-06
• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: External beam radiotherapy	external beam proton radiation therapy.	A total of 20 patients will be irradiated with protons after photon IMRT

Primary Outcome Measures

Name	Time	Method
Local response	90 days	RECIST criteria
Acute toxicity	90 days	According to CTCAE v4.0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CNAO; 🇮🇹 Pavia, Italy