Back to resultsProton Boost for Locally Advanced HEAD AND NECK TUMORS
Primary Purpose
Epithelial Tumor, Malignant, Neuroendocrine Tumors
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
external beam proton radiation therapy.
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Tumor, Malignant
Eligibility Criteria
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
Sites / Locations
- CNAO
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: External beam radiotherapy
Arm Description
A total of 20 patients will be irradiated with protons after photon IMRT
Outcomes
Primary Outcome Measures
Local response
RECIST criteria
Acute toxicity
According to CTCAE v4.0
Secondary Outcome Measures
Local control
RECIST criteria on MRI evaluation
Disease free survival
RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse
Overall survival
On MRI and total body CT evaluation - months from RT treatment to death
Late toxicity
According to CTCAE v4.0 registered during follow up visits
Full Information
NCT ID
NCT03183271
First Posted
June 4, 2017
Last Updated
June 13, 2017
Sponsor
CNAO National Center of Oncological Hadrontherapy
1. Study Identification
Unique Protocol Identification Number
NCT03183271
Brief Title
Proton Boost for Locally Advanced HEAD AND NECK TUMORS
Official Title
Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 16, 2012 (Actual)
Primary Completion Date
March 30, 2015 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CNAO National Center of Oncological Hadrontherapy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Tumor, Malignant, Neuroendocrine Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: External beam radiotherapy
Arm Type
Experimental
Arm Description
A total of 20 patients will be irradiated with protons after photon IMRT
Intervention Type
Radiation
Intervention Name(s)
external beam proton radiation therapy.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local response
Description
RECIST criteria
Time Frame
90 days
Title
Acute toxicity
Description
According to CTCAE v4.0
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Local control
Description
RECIST criteria on MRI evaluation
Time Frame
5 years
Title
Disease free survival
Description
RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse
Time Frame
5 years
Title
Overall survival
Description
On MRI and total body CT evaluation - months from RT treatment to death
Time Frame
5 years
Title
Late toxicity
Description
According to CTCAE v4.0 registered during follow up visits
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CNAO
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Proton Boost for Locally Advanced HEAD AND NECK TUMORS
We'll reach out to this number within 24 hrs