Phase 3 Completed N=16 Randomized Treatment

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

Spinal Metastases

Source: ClinicalTrials.gov NCT02320825 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Feb 2019

Primary outcomePrimary: Local Tumor Control Using MRI or CT

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Local Tumor Control Using MRI or CT	—	—
SECONDARY Treatment-related Toxicity Using CTCAE v4.0	—	—
SECONDARY Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02320825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.