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Completed

NCT Number: NCT02320825

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

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.

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Key information

Conditions

Spinal Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stanford University Medical Center, Stanford, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single-fraction SRS

Radiation

high-dose hypofractionated SRS

Radiation

Quality of Life Measures

Behavioral

Primary outcomes

  1. 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

  1. Treatment-related Toxicity Using CTCAE v4.0

    Time frame: 2 years

    Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

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

    Time frame: 2 years

    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)

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Johns Hopkins University
  • Massachusetts General Hospital
  • Stanford University

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2014
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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