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Proton Boost for Locally Advanced HEAD AND NECK TUMORS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03183271
First Posted: June 12, 2017
Last Update Posted: June 14, 2017
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.
Information provided by (Responsible Party):
CNAO National Center of Oncological Hadrontherapy
  Purpose
The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).

Condition Intervention
Epithelial Tumor, Malignant Neuroendocrine Tumors Radiation: external beam proton radiation therapy.

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by CNAO National Center of Oncological Hadrontherapy:

Primary Outcome Measures:
  • Local response [ Time Frame: 90 days ]
    RECIST criteria

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


Secondary Outcome Measures:
  • 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


Enrollment: 20
Actual Study Start Date: July 16, 2012
Study Completion Date: September 30, 2016
Primary Completion Date: March 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
Italy
CNAO
Pavia, Italy, 27100
Sponsors and Collaborators
CNAO National Center of Oncological Hadrontherapy
  More Information

Responsible Party: CNAO National Center of Oncological Hadrontherapy
ClinicalTrials.gov Identifier: NCT03183271     History of Changes
Other Study ID Numbers: CNAO 06/2011
First Submitted: June 4, 2017
First Posted: June 12, 2017
Last Update Posted: June 14, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Head and Neck Neoplasms
Carcinoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Site