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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-16

Study Completion Date

2018-07-26

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.

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Detailed Description

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Conditions

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Spinal Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single-fraction SRS (24 Gy)

single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.

Group Type EXPERIMENTAL

single-fraction SRS

Intervention Type RADIATION

Quality of Life Measures

Intervention Type BEHAVIORAL

high-dose hypofractionated SRS (27 Gy in 3 fractions)

hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.

Group Type EXPERIMENTAL

high-dose hypofractionated SRS

Intervention Type RADIATION

Quality of Life Measures

Intervention Type BEHAVIORAL

Interventions

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single-fraction SRS

Intervention Type RADIATION

high-dose hypofractionated SRS

Intervention Type RADIATION

Quality of Life Measures

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No