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Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases

Primary Purpose

Spinal Metastases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
single-fraction SRS
high-dose hypofractionated SRS
Quality of Life Measures
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Metastases focused on measuring Stereotactic Radiosurgery (SRS), Single-Fraction, Hypofractionated, Spinal surgery, 14-233

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Stanford University Medical Center
  • John Hopkins Medical Center
  • Massachusetts General Hospital
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

single-fraction SRS (24 Gy)

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatment-related Toxicity Using CTCAE v4.0
Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI
will be determined through patient-reported responses of the BPI. Pain severity at its worst (question #5) and the average of the pain interference (average of question #9)

Full Information

First Posted
December 16, 2014
Last Updated
January 31, 2019
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Johns Hopkins University, Massachusetts General Hospital, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02320825
Brief Title
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
Official Title
Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 16, 2014 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Johns Hopkins University, Massachusetts General Hospital, Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
Stereotactic Radiosurgery (SRS), Single-Fraction, Hypofractionated, Spinal surgery, 14-233

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single-fraction SRS (24 Gy)
Arm Type
Experimental
Arm Description
single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.
Arm Title
high-dose hypofractionated SRS (27 Gy in 3 fractions)
Arm Type
Experimental
Arm Description
hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.
Intervention Type
Radiation
Intervention Name(s)
single-fraction SRS
Intervention Type
Radiation
Intervention Name(s)
high-dose hypofractionated SRS
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Measures
Primary Outcome Measure Information:
Title
Local Tumor Control Using MRI or CT
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Treatment-related Toxicity Using CTCAE v4.0
Description
Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
2 years
Title
Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI
Description
will be determined through patient-reported responses of the BPI. Pain severity at its worst (question #5) and the average of the pain interference (average of question #9)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Laufer
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
John Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases

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