Verification of Novel Survival Prediction Algorithm for Patients With NSCLC Spinal Metastasis

• Conditions: Spinal Metastases; Non-Small-Cell Lung Cancer Metastatic

• Registration Number: NCT03363685
• Lead Sponsor: Ruijin Hospital

Brief Summary

The purpose of this study is to learn whether our own made predictive algorithm can be used as a clinical practical decision support for patients with NSCLC spinal metastasis. The scoring system consists of the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history. By predicting survival doctors could determine which patients are suitable for palliative therapy.

Detailed Description

Investigators have performed a retrospective study on 176 patients with NSCLC spinal metastasis under the oversight of hospital's ethics committee, and investigators found that the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history had significant association with survival. Then investigators built a simple, easy to use scoring system based on the features mentioned above. The score was calculated as 1 (for patients didn't receive EGFR-TKI), +2 (for KPS \<50%), +1 (for KPS 50-70%), +1 (Age \>60years), 2 (SCC ≥1.5ng/ml), +3 (CA125 ≥35 U/ml), +1 (smoking history 1-10/day), +2 (smoking history \>10/day), and 0 otherwise. This algorithm was used to divide the patients into low risk (0-3), intermediate risk (4-6), high risk groups (7-10) to predict survival and determine which patients are suitable for palliative therapy. Now investigators wish to register this study to do a further research, in order to verify the accuracy and sensitivity of this algorithm.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Diagnosis by biopsy: Non-small-cell lung cancer, including non-squamous carcinoma and squamous cell carcinoma.
• Diagnosis through both nucleotide bone scan and MRI or PET-CT: spinal metastasis.
• Age 18-75 years.
• Have been or is about to be treated according to NCCN panel recommendation.

Exclusion Criteria

• Diagnosis by biopsy: other tumors.
• Irregular follow-up and lost follow-up
• Withdraw from the study for any reason

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual survival of NSCLC spinal metastasis patients from 3 different risk groups.

Secondary Outcome Measures

Name	Time	Method
The Spinal Instability Neoplastic Score (SINS)	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	Assessment of spinal instability (0-18, higher value represents worse instability)
Primary and Metastatic Lesions	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	Differences in the primary and metastatic lesions after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups.
Serum Markers	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	Differences in the serum markers after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups.
Ambulatory Status	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	Assessment of walking ability
Visceral Metastasis	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	The correlation between visceral metastasis and overall survival (OS) of NSCLC spinal metastasis patients
Visual Analogue Scale (VAS)	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	Assessment of pain level (1-10, higher value represents more pain)
EORTC Quality of Life Questionnaire (QLQ) Bone metastasis (BM) 22,	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	Assessment of quality of life (22-88, higher value represents worse quality of life)
Modified Frankel grade	Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years	Assessment of neurological function (A-E, higher value represents better function)

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China