NCT02320825
Completed
Phase 3
Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
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
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.
Investigators
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)
Study Sites (4)
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