Proton Radiation Therapy for Spinal Tumors (NF01)

February 9, 2017 updated by: University of Florida

Spinal Tumor Proton Protocol

The purpose of this study is to determine if Proton Therapy can provide effective and safe treatment for Malignant Peripheral Nerve Sheath Tumors of the spine and Neurofibromas of the spine.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Proton therapy may provide the benefits of local control or palliation, while reducing the risk associated with photon radiation, by delivering therapeutic doses to a well-defined target area with significant reduction in the integral dose. A dosimetry comparison of protons and photons at the University of Florida Proton Therapy Institute confirmed the feasibility of proton irradiation of these tumors with less exposure of normal tissue to radiation than expected with photon techniques. This reduced radiation exposure to uninvolved normal tissues is expected to decrease the risk of radiation-induced second malignancies and neoplasms.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • MPNSTs that are biopsy-positive and resected, subtotally resected or unresectable.
  • Symptomatic (pain, numbness, or weakness) NF1 neurofibromas that are biopsy-positive and unresectable or subtotally resected.
  • Symptomatic NF1 neurofibromas that are unbiopsied and PET-negative, if the patient refuses biopsy/surgery or is medically inoperable.
  • Asymptomatic NF1 neurofibromas with radiologic progression after surgery.
  • PET-positive, unbiopsied lesions in NF1 patients who refuse biopsy/surgery or are medically inoperable.

Exclusion Criteria:

  • Spinal instability.
  • Metal stabilization hardware within the target area.
  • Previously irradiated at this disease site.
  • Spinal cord compression with complete loss of function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proton Radiation for MPNST
Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction
Radiation: Proton Radiation for MPNST
30 CGE at 6 CGE/Fx
Experimental: Proton Radiation for neurofibromas
Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction
Radiation: Proton Radiation for neurofibromas
25 CGE at 5 CGE/Fx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local Control
Time Frame: 7 years after completion of RT
7 years after completion of RT

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression or palliation of pain, numbness, or weakness
Time Frame: At 3, 6, 12, 24 and 60 months after RT
At 3, 6, 12, 24 and 60 months after RT
Number of adverse events
Time Frame: At 3, 6, 12, 24, 60 months and 15 years after RT
At 3, 6, 12, 24, 60 months and 15 years after RT
Quality of Life
Time Frame: 3, 6, 12, 24 and 60 months after RT
3, 6, 12, 24 and 60 months after RT
Rate of malignant transformation within the high-dose volume
Time Frame: 15 years after RT
15 years after RT
Rate of second malignant primaries outside of high dose volume, but located in tissues exposed to radiation within the beam path
Time Frame: 15 years after RT
15 years after RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Randal H Henderson, MD, University of Florida Proton Therapy Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 28, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 1101-NF01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurofibroma

Clinical Trials on Proton Radiation for MPNST

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe