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

Spinal Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320825
• Other study ID #: 14-233
• Status: Completed
• Phase: Phase 3
• Start date: December 16, 2014
• Est. completion date: July 26, 2018

Study information

• Verified date: January 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

Radiation:
• single-fraction SRS

• high-dose hypofractionated SRS

Behavioral:
• Quality of Life Measures

Locations

Country	Name	City	State
United States	John Hopkins Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Stanford University Medical Center	Stanford	California

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Johns Hopkins University, Massachusetts General Hospital, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 years
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	2 years
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)	2 years

External Links

•   Memorial Sloan Kettering Cancer Center