NCT00853528

Brief Summary

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

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

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

4.4 years

First QC Date

February 27, 2009

Last Update Submit

July 17, 2017

Conditions

Metastatic Cancer

Keywords

spinal cord metastases

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose - single fraction

    Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

    6 weeks

  • Maximum tolerated dose - hypofraction

    Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

    6 weeks

Secondary Outcomes (2)

  • Assessment of pain

    baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment

  • Spinal cord response

    baseline and then at 6 weeks and 6 months after completion of treatment

Study Arms (6)

Single-fraction radiosurgery; 16 Gray

EXPERIMENTAL

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Other: questionnaire administrationProcedure: diffusion tensor imagingProcedure: functional magnetic resonance imagingRadiation: single-fraction SRS

Hypo-fractionated radiosurgery; 21 Gray

EXPERIMENTAL

Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray

Other: questionnaire administrationProcedure: diffusion tensor imagingProcedure: functional magnetic resonance imagingRadiation: hypo-fractionated SRS

Single-fraction radiosurgery; 18 Gray

EXPERIMENTAL

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Other: questionnaire administrationProcedure: diffusion tensor imagingProcedure: functional magnetic resonance imagingRadiation: single-fraction SRS

Single-fraction radiosurgery; 20 Gray

EXPERIMENTAL

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Other: questionnaire administrationProcedure: diffusion tensor imagingProcedure: functional magnetic resonance imagingRadiation: single-fraction SRS

Hypo-fractionated radiosurgery; 24 Gray

EXPERIMENTAL

Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray

Other: questionnaire administrationProcedure: diffusion tensor imagingProcedure: functional magnetic resonance imagingRadiation: hypo-fractionated SRS

Hypo-fractionated radiosurgery; 27 Gray

EXPERIMENTAL

Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray

Other: questionnaire administrationProcedure: diffusion tensor imagingProcedure: functional magnetic resonance imagingRadiation: hypo-fractionated SRS

Interventions

questionnaire administrationOTHER

prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment

Hypo-fractionated radiosurgery; 21 GrayHypo-fractionated radiosurgery; 24 GrayHypo-fractionated radiosurgery; 27 GraySingle-fraction radiosurgery; 16 GraySingle-fraction radiosurgery; 18 GraySingle-fraction radiosurgery; 20 Gray
diffusion tensor imagingPROCEDURE

prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy

Hypo-fractionated radiosurgery; 21 GrayHypo-fractionated radiosurgery; 24 GrayHypo-fractionated radiosurgery; 27 GraySingle-fraction radiosurgery; 16 GraySingle-fraction radiosurgery; 18 GraySingle-fraction radiosurgery; 20 Gray
functional magnetic resonance imagingPROCEDURE

prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter

Hypo-fractionated radiosurgery; 21 GrayHypo-fractionated radiosurgery; 24 GrayHypo-fractionated radiosurgery; 27 GraySingle-fraction radiosurgery; 16 GraySingle-fraction radiosurgery; 18 GraySingle-fraction radiosurgery; 20 Gray
hypo-fractionated SRSRADIATION

two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy

Hypo-fractionated radiosurgery; 21 GrayHypo-fractionated radiosurgery; 24 GrayHypo-fractionated radiosurgery; 27 Gray
single-fraction SRSRADIATION

two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy

Single-fraction radiosurgery; 16 GraySingle-fraction radiosurgery; 18 GraySingle-fraction radiosurgery; 20 Gray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed metastatic spinal tumor
  • Localized spinal metastasis, defined as one of the following:
  • Solitary spinal metastasis
  • Two contiguous spinal levels
  • No more than 2 adjacent spinal levels involved by a single tumor
  • Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
  • Tumor size ≤ 5 cm
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 6 months
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be ambulatory

You may not qualify if:

  • Not pregnant or nursing
  • No spinal instability
  • No rapid neurological decline
  • No bony retropulsions causing neurological abnormalities
  • No total paraplegia for \> 48 hours
  • No psychological issues that would preclude completion of study treatment
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields
  • No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance
  • No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Minh-Tam Truong, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a Phase I study with 2 parallel groups of dose escalation using a 3 +3 design to determine the maximum tolerated dose of the radiation with the FDA approved device. There are three dose cohorts in each group, thus 6 arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMC Attending Physician

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data.

Locations

US(1)