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

Phase 3

Completed

• Conditions: Spinal Metastases
• Interventions: Radiation: single-fraction SRS; Radiation: high-dose hypofractionated SRS; Behavioral: Quality of Life Measures

• Registration Number: NCT02320825
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-16
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2019-01
• Results First Submitted: 2019-01-31
• Results First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Results First Posted: 2019-02-19
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single-fraction SRS (24 Gy)	single-fraction SRS	single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.
high-dose hypofractionated SRS (27 Gy in 3 fractions)	high-dose hypofractionated SRS	hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.
single-fraction SRS (24 Gy)	Quality of Life Measures	single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.
high-dose hypofractionated SRS (27 Gy in 3 fractions)	Quality of Life Measures	hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.

Primary Outcome Measures

Name	Time	Method
Local Tumor Control Using MRI or CT	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 Outcome Measures

Name	Time	Method
Treatment-related Toxicity Using CTCAE v4.0	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
Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI	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)

Trial Locations

Locations (4)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

John Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States