Trial Outcomes & Findings for Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases (NCT NCT02320825)

NCT ID: NCT02320825

Last Updated: 2019-02-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

16 participants

Primary outcome timeframe

2 years

Results posted on

2019-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-dose Hypofractionated SRS (27 Gy in 3 Fractions) n=8 Participants 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	Single-fraction SRS (24 Gy) n=8 Participants single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures	Total n=16 Participants Total of all reporting groups
Age, Continuous	55.125 years n=5 Participants	59.75 years n=7 Participants	57.44 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data were not collected

Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data were not collected

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)

Outcome measures

Outcome data not reported

Adverse Events

High-dose Hypofractionated SRS (27 Gy in 3 Fractions)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 7 deaths

Single-fraction SRS (24 Gy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	High-dose Hypofractionated SRS (27 Gy in 3 Fractions) n=8 participants at risk 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	Single-fraction SRS (24 Gy) n=8 participants at risk single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures
Gastrointestinal disorders Esophagitis	12.5% 1/8 • 2 years	0.00% 0/8 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ilya Laufer, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-2368

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place