Proton Boost for Locally Advanced HEAD AND NECK TUMORS

Sponsor

CNAO National Center of Oncological Hadrontherapy (Other)

Overall Status

Completed

CT.gov ID

NCT03183271

Collaborator

(none)

Enrollment

Location

Arm

50.5

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Epithelial Tumor, Malignant Neuroendocrine Tumors	Radiation: external beam proton radiation therapy.	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

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 :

Jul 16, 2012

Actual Primary Completion Date :

Mar 30, 2015

Actual Study Completion Date :

Sep 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: External beam radiotherapy 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.

Arm

Intervention/Treatment

Experimental: Experimental: External beam radiotherapy

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.

Outcome Measures

Primary Outcome Measures

Local response [90 days]
RECIST criteria
Acute toxicity [90 days]
According to CTCAE v4.0

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CNAO	Pavia		Italy	27100

Sponsors and Collaborators

CNAO National Center of Oncological Hadrontherapy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CNAO National Center of Oncological Hadrontherapy

ClinicalTrials.gov Identifier:

NCT03183271

Other Study ID Numbers:

CNAO 06/2011

First Posted:

Jun 12, 2017

Last Update Posted:

Jun 14, 2017

Last Verified:

Jun 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Neuroendocrine Tumors

Head and Neck Neoplasms

Carcinoma

Study Results

No Results Posted as of Jun 14, 2017