Proton Boost for Locally Advanced HEAD AND NECK TUMORS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03183271|
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Tumor, Malignant Neuroendocrine Tumors||Radiation: external beam proton radiation therapy.||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS|
|Actual Study Start Date :||July 16, 2012|
|Actual Primary Completion Date :||March 30, 2015|
|Actual Study Completion Date :||September 30, 2016|
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.
- Local response [ Time Frame: 90 days ]RECIST criteria
- Acute toxicity [ Time Frame: 90 days ]According to CTCAE v4.0
- Local control [ Time Frame: 5 years ]RECIST criteria on MRI evaluation
- Disease free survival [ Time Frame: 5 years ]RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse
- Overall survival [ Time Frame: 5 years ]On MRI and total body CT evaluation - months from RT treatment to death
- Late toxicity [ Time Frame: 5 years ]According to CTCAE v4.0 registered during follow up visits
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183271
|Pavia, Italy, 27100|