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Completed

NCT Number: NCT03183271

Proton Boost for Locally Advanced HEAD AND NECK TUMORS

The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).

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Key information

Conditions

Epithelial Tumor, Malignant Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CNAO

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

external beam proton radiation therapy.

Radiation

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 outcomes

  1. Local response

    Time frame: 90 days

    RECIST criteria

  2. Acute toxicity

    Time frame: 90 days

    According to CTCAE v4.0

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

CNAO National Center of Oncological Hadrontherapy

Other

Registry information

Official study title

Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jun 12, 2017
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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