NCT00573872

Brief Summary

Phase I of the study (motion and quality assurance \[QA\] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 20, 2017

Completed
Last Updated

December 5, 2017

Status Verified

October 1, 2017

Enrollment Period

11.4 years

First QC Date

December 12, 2007

Results QC Date

August 8, 2017

Last Update Submit

October 30, 2017

Conditions

NeoplasmArteriovenous Malformations

Keywords

RadiosurgeryPhase IICancerSpinalAVM

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy

    Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as "worse", "stable", "better", or "completely resolved". In the reporting "better" or "completely resolved" indicates response to treatment.

    2 years

  • Assess the Acute and Late Toxicity of Spinal Radiosurgery

    CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.

    2 years

  • Number of Participants With Lack of Tumor Growth at Last Follow-up

    Lack of tumor growth by CT or MRI at last follow-up

    2 years

Study Arms (1)

Spinal Radiosurgery

EXPERIMENTAL

Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.

Radiation: Radiosurgery

Interventions

RadiosurgeryRADIATION

Phase I: 20-25 Gy in 5 fractions Phase II: 9-24 GY in 1 fraction

Spinal Radiosurgery

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects must have history of histologically confirmed neoplasm or radiographically-diagnosed AVM. Patients without a prior tissue diagnosis but who have a radiographically characteristic lesion are eligible if there is consensus agreement of the diagnosis in the UAB Neuro-oncology Tumor Board.
  • ECOG performance status of less than or equal to 2
  • Age greater than 18
  • Life expectancy greater than 12 weeks
  • Subjects given written informed consent

You may not qualify if:

  • Cytotoxic chemotherapy within 7 days of treatment
  • Insufficient recovery from all active toxicities of prior therapies
  • Epidural spinal cord compression requiring immediate neurosurgical decompression. If a patient requires immediate surgery for neurologic compromise, they may still be eligible post operatively if tumor was incompletely resected.
  • Patient is non-ambulatory. Optimization of pretreatment neurologic function with steroids is allowed. Ambulation with assistance of walker or cane is allowed.
  • Patient is pregnant and it is judged by the treating Radiation Oncologist that spinal radiosurgery would place the fetus in unacceptable danger.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham/The Kirklin Clinic at Acton Road

Birmingham, Alabama, 35233, United States

Location

Related Publications (11)

  • Abbatucci JS, Delozier T, Quint R, Roussel A, Brune D. Radiation myelopathy of the cervical spinal cord: time, dose and volume factors. Int J Radiat Oncol Biol Phys. 1978 Mar-Apr;4(3-4):239-48. doi: 10.1016/0360-3016(78)90144-x. No abstract available.

    PMID: 640895BACKGROUND

  • Ang KK, Jiang GL, Feng Y, Stephens LC, Tucker SL, Price RE. Extent and kinetics of recovery of occult spinal cord injury. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):1013-20. doi: 10.1016/s0360-3016(01)01599-1.

    PMID: 11429229BACKGROUND

  • Bilsky MH, Yamada Y, Yenice KM, Lovelock M, Hunt M, Gutin PH, Leibel SA. Intensity-modulated stereotactic radiotherapy of paraspinal tumors: a preliminary report. Neurosurgery. 2004 Apr;54(4):823-30; discussion 830-1. doi: 10.1227/01.neu.0000114263.01917.1e.

    PMID: 15046647BACKGROUND

  • Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.

    PMID: 6646795BACKGROUND

  • Delattre JY, Rosenblum MK, Thaler HT, Mandell L, Shapiro WR, Posner JB. A model of radiation myelopathy in the rat. Pathology, regional capillary permeability changes and treatment with dexamethasone. Brain. 1988 Dec;111 ( Pt 6):1319-36. doi: 10.1093/brain/111.6.1319.

    PMID: 3208060BACKGROUND

  • Gerszten PC, Ozhasoglu C, Burton SA, Vogel WJ, Atkins BA, Kalnicki S, Welch WC. CyberKnife frameless stereotactic radiosurgery for spinal lesions: clinical experience in 125 cases. Neurosurgery. 2004 Jul;55(1):89-98; discussion 98-9.

    PMID: 15214977BACKGROUND

  • Glanzmann C, Aberle HG, Horst W. The risk of chronic progressive radiation myelopathy. Strahlentherapie. 1976 Oct;152(4):363-72.

    PMID: 982487BACKGROUND

  • Nieder C: Recommendation of Human Spinal Cord Re-irradiation Dose Based on Data From 39 Patients. Int J Radiat Oncol Biol Phys 57:373, 2003

    BACKGROUND

  • Schultheiss TE, Stephens LC. Invited review: permanent radiation myelopathy. Br J Radiol. 1992 Sep;65(777):737-53. doi: 10.1259/0007-1285-65-777-737. No abstract available.

    PMID: 1393407BACKGROUND

  • Schultheiss TE, Stephens LC, Jiang GL, Ang KK, Peters LJ. Radiation myelopathy in primates treated with conventional fractionation. Int J Radiat Oncol Biol Phys. 1990 Oct;19(4):935-40. doi: 10.1016/0360-3016(90)90015-c.

    PMID: 2211262BACKGROUND

  • Schultheiss TE, Stephens LC, Maor MH. Analysis of the histopathology of radiation myelopathy. Int J Radiat Oncol Biol Phys. 1988 Jan;14(1):27-32. doi: 10.1016/0360-3016(88)90046-6.

    PMID: 3275603BACKGROUND

MeSH Terms

Conditions

NeoplasmsArteriovenous Malformations

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
John Fiveash, MD
Organization
University of Alabama at Birmingham
jfiveash@uabmc.edu
205-975-0224

Study Officials

  • John B. Fiveash, M.D.

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

April 1, 2005

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 5, 2017

Results First Posted

October 20, 2017

Record last verified: 2017-10

Locations

US(1)