NCT03183271CompletedNot Applicable
Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS
CNAO National Center of Oncological Hadrontherapy2 sites in 1 country20 target enrollmentStarted: July 16, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Local response
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Local response
Time Frame: 90 days
RECIST criteria
Acute toxicity
Time Frame: 90 days
According to CTCAE v4.0
Secondary Outcomes
- Local control(5 years)
- Disease free survival(5 years)
- Overall survival(5 years)
- Late toxicity(5 years)
Investigators
Study Sites (2)
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