Proton Boost for Locally Advanced HEAD AND NECK TUMORS

June 13, 2017 updated by: CNAO National Center of Oncological Hadrontherapy

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

The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • CNAO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local response
Time Frame: 90 days
RECIST criteria
90 days
Acute toxicity
Time Frame: 90 days
According to CTCAE v4.0
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CNAO National Center of Oncological Hadrontherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2012

Primary Completion (Actual)

March 30, 2015

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

June 4, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNAO 06/2011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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