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)

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

NCT02320825

14-233

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