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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Metastases

Intervention / Treatment
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* Radiation: single-fraction SRS
* Radiation: high-dose hypofractionated SRS
* Behavioral: Quality of Life Measures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-fraction SRS (24 Gy)<br>single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. | Radiation: single-fraction SRS<br> <br> Behavioral: Quality of Life Measures<br> <br> |
| Experimental: high-dose hypofractionated SRS (27 Gy in 3 fractions)<br>hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery. | Radiation: high-dose hypofractionated SRS<br> <br> Behavioral: Quality of Life Measures<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 
| 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) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic Radiosurgery (SRS), Single-Fraction, Hypofractionated, Spinal surgery, 14-233