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A Phase II Study of Spinal Radiosurgery (RAD0408)

Primary Purpose

Neoplasm, Arteriovenous Malformations

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Radiosurgery

About this trial

This is an interventional treatment trial for Neoplasm focused on measuring Radiosurgery, Phase II, Cancer, Spinal, AVM

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Radiosurgery

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00573872

First Posted

December 12, 2007

Last Updated

October 30, 2017

Sponsor

University of Alabama at Birmingham

Collaborators

Health Services Foundation, The Kirklin Clinic at Acton Road

1. Study Identification

Unique Protocol Identification Number

NCT00573872

Brief Title

A Phase II Study of Spinal Radiosurgery

Acronym

RAD0408

Official Title

A Phase II Study of Spinal Radiosurgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

April 2005 (Actual)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

Health Services Foundation, The Kirklin Clinic at Acton Road

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study. Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area: Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = <50% CTV dose/No previous RT = <80% CTV dose. Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy. # Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery. *Previous RT: greater than six months since completion of RT at least 20 Gy, but no more than 50 Gy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasm, Arteriovenous Malformations

Keywords

Radiosurgery, Phase II, Cancer, Spinal, AVM

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Spinal Radiosurgery

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiosurgery

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 years

Title

Assess the Acute and Late Toxicity of Spinal Radiosurgery

Description

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.

Time Frame

2 years

Title

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

Description

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John B. Fiveash, M.D.

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

640895

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

15046647

Citation

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.

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PubMed Identifier

6646795

Citation

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PubMed Identifier

3208060

Citation

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.

Results Reference

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PubMed Identifier

15214977

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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

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Citation

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

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PubMed Identifier

1393407

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

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Citation

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Results Reference

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A Phase II Study of Spinal Radiosurgery

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