NCT02320825

Brief Summary

The purpose of this study is to find out whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2014

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

December 16, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 19, 2019

Completed
Last Updated

February 19, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

December 16, 2014

Results QC Date

January 31, 2019

Last Update Submit

January 31, 2019

Conditions

Spinal Metastases

Keywords

Stereotactic Radiosurgery (SRS)Single-FractionHypofractionatedSpinal surgery14-233

Outcome Measures

Primary Outcomes (1)

  • Local Tumor Control Using MRI or CT

    will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging.

    2 years

Secondary Outcomes (2)

  • Treatment-related Toxicity Using CTCAE v4.0

    2 years

  • Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI

    2 years

Study Arms (2)

single-fraction SRS (24 Gy)

EXPERIMENTAL

single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.

Radiation: single-fraction SRSBehavioral: Quality of Life Measures

high-dose hypofractionated SRS (27 Gy in 3 fractions)

EXPERIMENTAL

hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.

Radiation: high-dose hypofractionated SRSBehavioral: Quality of Life Measures

Interventions

single-fraction SRSRADIATION
single-fraction SRS (24 Gy)
high-dose hypofractionated SRSRADIATION
high-dose hypofractionated SRS (27 Gy in 3 fractions)
Quality of Life MeasuresBEHAVIORAL
high-dose hypofractionated SRS (27 Gy in 3 fractions)single-fraction SRS (24 Gy)

Eligibility Criteria

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

You may qualify if:

  • Histologically diagnosed metastatic cancer (Diagnosis made or confirmed at MSKCC for MSKCC participants. Institutional pathologic determination accepted from participating multicenter sites.)
  • Age ≥18 years
  • Life expectancy ≥3 months
  • ECOG ≤ 3
  • Spinal surgery carried out with the goal of spinal cord decompression and spinal stabilization within 8 weeks
  • Post-operative CT myelogram or MRI perfusion with evidence of separation of tumor and the spinal cord It should be noted that patients with multiple lesions will be eligible as long as there are no overlapping fields of radiation, including at various time frames.

You may not qualify if:

  • Primary spine tumor
  • Age \< 18
  • Pregnancy
  • Lack of adequate (≥ 2 mm) separation between the spinal cord and the tumor on post-operative CT myelogram or MRI perfusion
  • Radiosensitizing chemotherapy (taxol, taxotere, cisplatin, gemcitabine, 5-fluorouracil) given within one week of radiation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

John Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Results Point of Contact

Title
Dr. Ilya Laufer, MD
Organization
Memorial Sloan Kettering Cancer Center
lauferi@mskcc.org
212-639-2368

Study Officials

  • Ilya Laufer

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

December 16, 2014

Primary Completion

July 26, 2018

Study Completion

July 26, 2018

Last Updated

February 19, 2019

Results First Posted

February 19, 2019

Record last verified: 2019-01

Locations

US(4)