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

Memorial Sloan Kettering Cancer Center4 sites in 1 country16 target enrollmentDecember 16, 2014

ConditionsSpinal Metastases

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Spinal Metastases
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 16
Locations: 4
Primary Endpoint: Local Tumor Control Using MRI or CT
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 16, 2014

End Date

July 26, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

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
•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

Outcomes

Primary Outcomes

Local Tumor Control Using MRI or CT

Time Frame: 2 years

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 Outcomes

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)