Pathological Fracture in Potentially Unstable Spinal Metastases of Breast Cancer

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03365973

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify potential risk factors for and determine the rate of pathological fracture for patients which having spine metastases from breast cancer and be defined as potentially unstable (SINS 7-12) according to the Spinal Instability Neoplastic Score (SINS). The investigators' analysis will provide robust data about the development of spinal instability and help identify the optimal timing of local surgery treatment.

Condition or Disease	Intervention/Treatment	Phase
Spinal Metastases Breast Cancer

Detailed Description

Considering the concept of spinal instability remains important in the clinical decision-making process for patients with spine metastases, the Spine Oncology Study Group (SOSG) devised an 18-point SINS, which proved reliable and has been widely used in clinical practice. Scores of 0-6, 7-12, 13-18 are considered stable, potentially unstable, and unstable, respectively. Lesions with a low SINS (score 0-6) do not requires surgical interventions, whereas a high SINS (score 13-18) predicts the need for surgical stabilization to restore spinal stability. However, treatment strategy of intermediate SINS (score 7-12) lesions remains ambiguous owing to the uncertainty of spinal stability. With the duration of spinal metastases, some potentially unstable lesions turn to be stable while some turn to be unstable, and several factors such as tumor involvement for vertebral body, radiotherapy may account for different outcomes. Owing to the relatively weaker growth and invasion ability of breast cancer cells compared to other solid tumors such as lung cancer and liver cancer, patients with breast cancer and spinal metastases have longer life expectancy. Reasonable and prompt local surgical intervention to restore spinal stability can achieve pain relief and better quality of life effectively. Moreover, most spinal metastases from breast cancer show lytic or mixed lytic-blastic bone lesions, which exacerbates the spinal stability and results in pathological fracture. Thus, investigators focus on patients which having spinal metastases from breast cancer and an intermediate SINS (score 7-12) to explore the rate of pathological fracture and relevant risk factors. This study will help spine surgeon to identify who could benefit from a prophylactic stabilization procedure with high risk of pathological fracture and when is the best timing of surgery.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Pilot Study of Pathological Fracture Progression and Related Risk Factors for Patients With Potentially Unstable Spinal Metastases of Breast Cancer

Actual Study Start Date :

Dec 15, 2017

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Spinal metastases of breast cancer Patients with potentially unstable spinal metastases of breast cancer

Outcome Measures

Primary Outcome Measures

Rate of the pathological fracture of spine [First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years]
Pathological fracture will be detected using Magnetic Resonance Imaging (MRI)

Secondary Outcome Measures

Quality of life outcomes measured by EORTC QLQ-C30 questionnaire [First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years]
Quality of life outcomes measured by EORTC QLQ-BM22 questionnaire [First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years]
Pain and functional outcome data measured by Brief Pain Inventory (BPI) questionnaire [First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years]
Spinal stability measured by Spinal Instability Neoplastic Score (SINS) [First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years]
The Spine Instability Neoplastic Score (SINS) is a comprehensive classification system that can aid in predicting spine stability of neoplastic lesions. The 18-point SINS includes global spinal location of the tumor (score 0-3), type and presence of pain (score 0-3), bone lesion quality (score 0-2), spinal alignment (score 0-4), extent of vertebral body collapse (score 0-3), and posterolateral spinal element involvement (score 0-3). As the SINS increases, the spine stability of neoplastic lesions turns to be worse
Neurologic outcome measured by Frankel grading system [First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-65 years, female
Had a histological confirmation of breast cancer, including all pathological types
Had a histological or radiological confirmation of spinal metastases from breast cancer
SINS 7-12

Exclusion Criteria:

Prior prophylactic stabilization surgery to the spine at current level of interest
Patients with other malignancies except breast cancer
Misdiagnosis of spinal metastases from breast cancer confirmed by pathological examination
Patients without undergoing follow-up on schedule
Withdraw from the study for any reason