Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: single-fraction SRS (24 Gy) single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. |
Radiation: single-fraction SRS
Behavioral: Quality of Life Measures
|
| Experimental: 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. |
Radiation: high-dose hypofractionated SRS
Behavioral: Quality of Life Measures
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University Medical Center | Stanford | California | United States | 94305-5408 |
| 2 | John Hopkins Medical Center | Baltimore | Maryland | United States | 21287 |
| 3 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 4 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- Johns Hopkins University
- Massachusetts General Hospital
- Stanford University
Investigators
- Principal Investigator: Ilya Laufer, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 14-233
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | Single-fraction SRS (24 Gy) |
|---|---|---|
| Arm/Group Description | 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 (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures |
| Period Title: Overall Study | ||
| STARTED | 8 | 8 |
| COMPLETED | 8 | 8 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | Single-fraction SRS (24 Gy) | Total |
|---|---|---|---|
| Arm/Group Description | 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 (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures | Total of all reporting groups |
| Overall Participants | 8 | 8 | 16 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
55.125
|
59.75
|
57.44
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
12.5%
|
5
62.5%
|
6
37.5%
|
| Male |
7
87.5%
|
3
37.5%
|
10
62.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
12.5%
|
1
6.3%
|
| White |
7
87.5%
|
7
87.5%
|
14
87.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
12.5%
|
0
0%
|
1
6.3%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
8
100%
|
8
100%
|
16
100%
|
Outcome Measures
| Title | Local Tumor Control Using MRI or CT |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Single-fraction SRS (24 Gy) | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) |
|---|---|---|
| Arm/Group Description | single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures | 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 |
| Measure Participants | 0 | 0 |
| Title | Treatment-related Toxicity Using CTCAE v4.0 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Single-fraction SRS (24 Gy) | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) |
|---|---|---|
| Arm/Group Description | single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures | 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 |
| Measure Participants | 0 | 0 |
| Title | Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Single-fraction SRS (24 Gy) | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) |
|---|---|---|
| Arm/Group Description | single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures | 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 |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | 2 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | Single-fraction SRS (24 Gy) | ||
| Arm/Group Description | 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 (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures | ||
All Cause Mortality |
||||
| High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | Single-fraction SRS (24 Gy) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/8 (87.5%) | 5/8 (62.5%) | ||
Serious Adverse Events |
||||
| High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | Single-fraction SRS (24 Gy) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/8 (12.5%) | 0/8 (0%) | ||
| Gastrointestinal disorders | ||||
| Esophagitis | 1/8 (12.5%) | 0/8 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | Single-fraction SRS (24 Gy) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Ilya Laufer, MD |
|---|---|
| Organization | Memorial Sloan Kettering Cancer Center |
| Phone | 212-639-2368 |
| lauferi@mskcc.org |
- 14-233