Cyberknife Radiosurgery for Patients With Neurinomas (ACOUNEU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor:
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier:
NCT02055859
First received: January 31, 2014
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

Most vestibular schwannomas are benign and slow-growing. Based on that fact, conservative management with serial imaging is a viable alternative. For patients who undergo treatment because of tumor growth, progressive symptoms, or personal preference, options include serial observation, microsurgical resection, fractionated stereotactic radiotherapy, and stereotactic single-session radiosurgery.

Despite improved radiosurgical techniques and lower marginal doses, a recent report has shown a somewhat disappointing 10-year actuarial hearing preservation rate of 44.5%, with hearing loss developing as much as 6 years after.

Fractionation of the prescribed dose may takes some advantages from radiobiologic principles to reduce toxicity and maintain tumor control.

Staged frame-based radiotherapy using a 12-hour interfraction interval was successfully used at Stanford university and has shown a hearing preservation rate of 77% at 2 years of follow-up.

The aim of the present protocol is to evaluate the hearing preservation, the local control and toxicity after single-session (sSRS) or multi-session (3 fractions) radiosurgery (mSRS) by using the frameless robotic CyberKnife® system (Accuray Incorporated, Sunnyvale, CA, USA).

In order to investigate about this a randomised controlled double harm (sSRS vs mSRS) trial was designed.


Condition Intervention Phase
Sporadic Acoustic Neuromas
Useful Hearing
Radiation: Radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cyberknife Radiosurgery for Patients With Neurinomas

Resource links provided by NLM:


Further study details as provided by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta:

Primary Outcome Measures:
  • Useful hearing preservation after single or multisession radiosurgery [ Time Frame: Change in auditory function will be registered 4 months after the treatment every 6 months during the 1st to the 3rd years and then annually or until hearing will be classified as "not serviceable hearing". ] [ Designated as safety issue: No ]

    The primary end point of this study is the spare of auditory function in patient with acoustic neuromas with 2 different radiosurgery protocols.

    The auditory function will be classified according to the American Academy of Otorhinolaryngology-Head and Neck Surgery classification) Spare of the auditory function is defined as the maintenance of the patients into the classes A and B.



Secondary Outcome Measures:
  • treatment effectiveness [ Time Frame: 4 months after treatment, then every 6 months for 2 years and then annually. ] [ Designated as safety issue: Yes ]
    tumor response: it will be evaluate on MRI images. Complete response (CR) is defined as the MRI disappearance of the lesion. Partial response (PR) is defined as 20%, decrease in the volumetric size of the lesion on MRI, stable disease (SD) as no change in the size of the lesion, and progressive disease (PD) increase in any volumetric size of the lesion, confirmed at least a the following two consecutive MRI.

  • treatment safety [ Time Frame: 4 months after treatment, then every 6 months for 2 years and then annually. ] [ Designated as safety issue: Yes ]
    The neurological toxicity (facial and trigeminal nerve especially) Trigeminal toxicity will be registered according to Barrow Neurological Institute pain intensity score (BPS), and Barrow Neurological Institute facial numbness score (BNS). Facial nerve function is graded on the House-Brackmann (H-B) scale.


Estimated Enrollment: 102
Study Start Date: April 2011
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single session radiosurgery
single session radiosurgery (gold standard)
Radiation: Radiosurgery
Other Name: Cyberknife (Accuray)
Experimental: multisession radiosurgery
multisession radiosurgery (3 fraction)
Radiation: Radiosurgery
Other Name: Cyberknife (Accuray)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sporadic acoustic neuroma max diameter 3 cm
  • Age: ≥ 18 years old
  • KPS ≥ 70
  • Serviceable hearing (class A and B from the American Academy of Otorhinolaryngology-Head and Neck Surgery classification)
  • Written consent

Exclusion Criteria:

  • Pregnancy
  • Allergy to contrast medium
  • Neurofibromatosis type 2 (NF2)
  • anacousia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055859

Contacts
Contact: Laura Fariselli, MD +39022394 ext 2157 lfariselli@istituto-besta.it

Locations
Italy
Istittuto Nazionale Neurologico Carlo Besta Recruiting
Milano, Mi, Italy, 20133
Contact: Laura Fariselli, MD    +39022394 ext 2157    fariselli.l@istituto-besta.it   
Sub-Investigator: Marcello Marchetti, MD         
Principal Investigator: Laura Fariselli, MD         
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Investigators
Principal Investigator: Laura Fariselli, MD Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  More Information

No publications provided

Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT02055859     History of Changes
Other Study ID Numbers: PR-Rt acouneu
Study First Received: January 31, 2014
Last Updated: February 4, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta:
acoustic neuromas
radiosurgery
hearing preservation

Additional relevant MeSH terms:
Neuroma, Acoustic
Neurilemmoma
Neuroma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014