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Spinal Tumor Proton Protocol


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Nerve Sheath Tumors, Neurofibroma

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Trial Information

Spinal Tumor Proton Protocol


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 MPNST 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local Control

Outcome Time Frame:

7 years after completion of RT

Safety Issue:

No

Principal Investigator

Randal H Henderson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 1101-NF01

NCT ID:

NCT01567787

Start Date:

June 2013

Completion Date:

May 2032

Related Keywords:

  • Nerve Sheath Tumors
  • Neurofibroma
  • Proton Radiation Therapy
  • Spinal tumors
  • Neurofibroma(NF1)
  • Malignant peripheral nerve sheath tumor(MPNST)
  • Neurofibroma
  • Spinal Cord Neoplasms
  • Spinal Neoplasms
  • Nerve Sheath Neoplasms

Name

Location

University of Florida Proton Therapy InstituteJacksonville, Florida  32206