Cyberknife Radiosurgery for Patients With Neurinomas

NCT02055859 | Unknown

• 1 other identifier: PR-Rt acouneu
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sporadic Acoustic Neuromas; Useful Hearing

Keywords

acoustic neuromas; radiosurgery; hearing preservation

Outcome Measures

Primary Outcomes (1)

• Useful hearing preservation after single or multisession radiosurgery

  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.

  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".

Secondary Outcomes (3)

• treatment effectiveness

  4 months after treatment, then every 6 months for 2 years and then annually.

• treatment safety of facial nerve

  4 months after treatment, then every 6 months for 2 years and then annually.

• treatment safety of trigeminal nerve

  4 months after treatment, then every 6 months for 2 years and then annually.

Study Arms (2)

single session radiosurgery

OTHER

single session radiosurgery (gold standard)

Radiation: Radiosurgery

multisession radiosurgery

EXPERIMENTAL

multisession radiosurgery (3 fraction)

Radiation: Radiosurgery

Interventions

Radiosurgery RADIATION

Also known as: Cyberknife (Accuray)

multisession radiosurgery; single session radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Allergy to contrast medium
• Neurofibromatosis type 2 (NF2)
• anacousia

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Istittuto Nazionale Neurologico Carlo Besta

Milan, Mi, 20133, Italy

Location

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laura Fariselli, MD

  Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 5, 2014
• Study Start: March 15, 2011
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2025
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

IT (1)