Spinal Metastases
Conditions
Keywords
Stereotactic Radiosurgery (SRS), Single-Fraction, Hypofractionated, Spinal surgery, 14-233
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.
Interventions
RADIATIONsingle-fraction SRS
RADIATIONhigh-dose hypofractionated SRS
BEHAVIORALQuality of Life Measures
Sponsors
Johns Hopkins University
Massachusetts General Hospital
Stanford University
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
high-dose hypofractionated SRS
Quality of Life Measures | 8 |
| Single-fraction SRS (24 Gy) single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.
single-fraction SRS
Quality of Life Measures | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | Total | Single-fraction SRS (24 Gy) |
|---|---|---|---|
| Age, Continuous | 55.125 years | 57.44 years | 59.75 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 8 | 5 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 1 / 8 | 0 / 8 |
Outcome results
Primary
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.
Time frame: 2 years
Population: Data were not collected
Secondary
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)
Time frame: 2 years
Population: Data were not collected
Secondary
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
Time frame: 2 years
Population: Data were not collected