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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed
Phase 3

Conditions

Spinal Metastases

Treatments

Radiation: high-dose hypofractionated SRS
Behavioral: Quality of Life Measures
Radiation: single-fraction SRS

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 2 patient groups

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

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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