Proton Radiation Therapy for Spinal Tumors

Neurofibroma Clinical Trial

— NF01  

Official title:

Spinal Tumor Proton Protocol

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01567787
• Other study ID #: UFPTI 1101-NF01
• Status: Withdrawn
• Phase: N/A
• First received: March 13, 2012
• Last updated: February 9, 2017
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: February 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Sheath Neoplasms
• Nerve Sheath Tumors
• Neurofibroma
• Neurofibromatoses
• Spinal Cord Neoplasms
• Spinal Neoplasms

Intervention

Radiation:
• Proton Radiation for MPNST
30 CGE at 6 CGE/Fx
• Proton Radiation for neurofibromas
25 CGE at 5 CGE/Fx

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control		7 years after completion of RT
Secondary	Progression or palliation of pain, numbness, or weakness		At 3, 6, 12, 24 and 60 months after RT
Secondary	Number of adverse events		At 3, 6, 12, 24, 60 months and 15 years after RT
Secondary	Quality of Life		3, 6, 12, 24 and 60 months after RT
Secondary	Rate of malignant transformation within the high-dose volume		15 years after RT
Secondary	Rate of second malignant primaries outside of high dose volume, but located in tissues exposed to radiation within the beam path		15 years after RT