NCT03183271

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

June 4, 2017

Last Update Submit

June 13, 2017

Conditions

Epithelial Tumor, MalignantNeuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

  • Local response

    RECIST criteria

    90 days

  • Acute toxicity

    According to CTCAE v4.0

    90 days

Secondary Outcomes (4)

  • Local control

    5 years

  • Disease free survival

    5 years

  • Overall survival

    5 years

  • Late toxicity

    5 years

Study Arms (1)

Experimental: External beam radiotherapy

EXPERIMENTAL

A total of 20 patients will be irradiated with protons after photon IMRT

Radiation: external beam proton radiation therapy.

Interventions

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.

Experimental: External beam radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNAO

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

CarcinomaNeuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2017

First Posted

June 12, 2017

Study Start

July 16, 2012

Primary Completion

March 30, 2015

Study Completion

September 30, 2016

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

IT(1)