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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
Sponsor:
Information provided by (Responsible Party):
CNAO National Center of Oncological Hadrontherapy

Study Description
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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. Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : July 16, 2012
Actual Primary Completion Date : March 30, 2015
Actual Study Completion Date : September 30, 2016

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Local response [ Time Frame: 90 days ]
    RECIST criteria

  2. Acute toxicity [ Time Frame: 90 days ]
    According to CTCAE v4.0


Secondary Outcome Measures :
  1. Local control [ Time Frame: 5 years ]
    RECIST criteria on MRI evaluation

  2. Disease free survival [ Time Frame: 5 years ]
    RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse

  3. Overall survival [ Time Frame: 5 years ]
    On MRI and total body CT evaluation - months from RT treatment to death

  4. Late toxicity [ Time Frame: 5 years ]
    According to CTCAE v4.0 registered during follow up visits


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Italy
CNAO
Pavia, Italy, 27100
Sponsors and Collaborators
CNAO National Center of Oncological Hadrontherapy
More Information
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Responsible Party: CNAO National Center of Oncological Hadrontherapy
ClinicalTrials.gov Identifier: NCT03183271    
Other Study ID Numbers: CNAO 06/2011
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms by Site
Neoplasms, Glandular and Epithelial