AzTrials
AzTrials

Nerve Sheath TumorsNF01NCT01567787

Proton Radiation Therapy for Spinal Tumors

A study testing Proton Radiation for MPNST and Proton Radiation for neurofibromas in people with Nerve Sheath Tumors and Neurofibroma, run by University of Florida.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nerve Sheath Tumors, Neurofibroma
What is being tested?
Proton Radiation for MPNST and Proton Radiation for neurofibromas
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2013to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Being tested
Proton Radiation for MPNST, Proton Radiation for neurofibromas
Keywords
Proton Radiation Therapy, Spinal tumors, Neurofibroma(NF1), Malignant peripheral nerve sheath tumor(MPNST)
Medical subject headings
Nerve Sheath Neoplasms, Neurofibroma, Spinal Cord Neoplasms, Neurofibrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton Radiation for MPNSTRadiation

    30 CGE at 6 CGE/Fx

  • Proton Radiation for neurofibromasRadiation

    25 CGE at 5 CGE/Fx

Study groups in NCT01567787
Study groupRoleWhat they receive
Proton Radiation for MPNSTExperimentalProton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction
Receives: Radiation: Proton Radiation for MPNST
Proton Radiation for neurofibromasExperimentalProton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction
Receives: Radiation: Proton Radiation for neurofibromas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local Control

    Measured: 7 years after completion of RT

Secondary outcomes (5)

  1. Progression or palliation of pain, numbness, or weakness

    Measured: At 3, 6, 12, 24 and 60 months after RT

  2. Number of adverse events

    Measured: At 3, 6, 12, 24, 60 months and 15 years after RT

  3. Quality of Life

    Measured: 3, 6, 12, 24 and 60 months after RT

  4. Rate of malignant transformation within the high-dose volume

    Measured: 15 years after RT

  5. Rate of second malignant primaries outside of high dose volume, but located in tissues exposed to radiation within the beam path

    Measured: 15 years after RT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2012 (estimated)
  2. Study startJun 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Why it stopped: Feasibility issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01567787
Sponsor's protocol ID
UFPTI 1101-NF01
Acronym
NF01
Status last verified
Feb 2017
First submitted
13 Mar 2012
Last updated
10 Feb 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hottinger AF, Khakoo Y. Neuro-oncology of Neurofibromatosis Type 1. Curr Treat Options Neurol. 2009 Jul;11(4):306-14. doi: 10.1007/s11940-009-0034-4.

    PubMed 19523356

  • Friedman JM, Birch PH. Type 1 neurofibromatosis: a descriptive analysis of the disorder in 1,728 patients. Am J Med Genet. 1997 May 16;70(2):138-43. doi: 10.1002/(sici)1096-8628(19970516)70:23.0.co;2-u.

    PubMed 9128932

  • Cnossen MH, de Goede-Bolder A, van den Broek KM, Waasdorp CM, Oranje AP, Stroink H, Simonsz HJ, van den Ouweland AM, Halley DJ, Niermeijer MF. A prospective 10 year follow up study of patients with neurofibromatosis type 1. Arch Dis Child. 1998 May;78(5):408-12. doi: 10.1136/adc.78.5.408.

    PubMed 9659085

  • Mautner VF, Asuagbor FA, Dombi E, Funsterer C, Kluwe L, Wenzel R, Widemann BC, Friedman JM. Assessment of benign tumor burden by whole-body MRI in patients with neurofibromatosis 1. Neuro Oncol. 2008 Aug;10(4):593-8. doi: 10.1215/15228517-2008-011. Epub 2008 Jun 17.

    PubMed 18559970

  • Seppala MT, Haltia MJ, Sankila RJ, Jaaskelainen JE, Heiskanen O. Long-term outcome after removal of spinal neurofibroma. J Neurosurg. 1995 Apr;82(4):572-7. doi: 10.3171/jns.1995.82.4.0572.

    PubMed 7897516

  • Thakkar SD, Feigen U, Mautner VF. Spinal tumours in neurofibromatosis type 1: an MRI study of frequency, multiplicity and variety. Neuroradiology. 1999 Sep;41(9):625-9. doi: 10.1007/s002340050814.

    PubMed 10525761

  • Tonsgard JH. Clinical manifestations and management of neurofibromatosis type 1. Semin Pediatr Neurol. 2006 Mar;13(1):2-7. doi: 10.1016/j.spen.2006.01.005.

    PubMed 16818170

  • Needle MN, Cnaan A, Dattilo J, Chatten J, Phillips PC, Shochat S, Sutton LN, Vaughan SN, Zackai EH, Zhao H, Molloy PT. Prognostic signs in the surgical management of plexiform neurofibroma: the Children's Hospital of Philadelphia experience, 1974-1994. J Pediatr. 1997 Nov;131(5):678-82. doi: 10.1016/s0022-3476(97)70092-1.

    PubMed 9403645

  • Ducatman BS, Scheithauer BW, Piepgras DG, Reiman HM, Ilstrup DM. Malignant peripheral nerve sheath tumors. A clinicopathologic study of 120 cases. Cancer. 1986 May 15;57(10):2006-21. doi: 10.1002/1097-0142(19860515)57:103.0.co;2-6.

    PubMed 3082508

  • Evans DG, Baser ME, McGaughran J, Sharif S, Howard E, Moran A. Malignant peripheral nerve sheath tumours in neurofibromatosis 1. J Med Genet. 2002 May;39(5):311-4. doi: 10.1136/jmg.39.5.311.

    PubMed 12011145

  • Ferner RE, Gutmann DH. International consensus statement on malignant peripheral nerve sheath tumors in neurofibromatosis. Cancer Res. 2002 Mar 1;62(5):1573-7.

    PubMed 11894862

  • Chao RC, Pyzel U, Fridlyand J, Kuo YM, Teel L, Haaga J, Borowsky A, Horvai A, Kogan SC, Bonifas J, Huey B, Jacks TE, Albertson DG, Shannon KM. Therapy-induced malignant neoplasms in Nf1 mutant mice. Cancer Cell. 2005 Oct;8(4):337-48. doi: 10.1016/j.ccr.2005.08.011.

    PubMed 16226708

  • Stiller CA, Chessells JM, Fitchett M. Neurofibromatosis and childhood leukaemia/lymphoma: a population-based UKCCSG study. Br J Cancer. 1994 Nov;70(5):969-72. doi: 10.1038/bjc.1994.431.

    PubMed 7947106

  • Huson SM, Compston DA, Harper PS. A genetic study of von Recklinghausen neurofibromatosis in south east Wales. II. Guidelines for genetic counselling. J Med Genet. 1989 Nov;26(11):712-21. doi: 10.1136/jmg.26.11.712.

    PubMed 2511319

  • Sharif S, Ferner R, Birch JM, Gillespie JE, Gattamaneni HR, Baser ME, Evans DG. Second primary tumors in neurofibromatosis 1 patients treated for optic glioma: substantial risks after radiotherapy. J Clin Oncol. 2006 Jun 1;24(16):2570-5. doi: 10.1200/JCO.2005.03.8349.

    PubMed 16735710

Questions about this trial

What is this clinical trial studying?

A study testing Proton Radiation for MPNST and Proton Radiation for neurofibromas in people with Nerve Sheath Tumors and Neurofibroma, run by University of Florida.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Control (time frame: 7 years after completion of RT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01567787, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.

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