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

Shanghai Jiao Tong University

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT03363685

RJ2017NO170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 3 patient groups

Low risk

Description:

For NSCLC spinal metastasis patients with 0-3 of novel survival prediction algorithm.

Intermediate risk

Description:

For NSCLC spinal metastasis patients with 4-6 of novel survival prediction algorithm.

High risk

Description:

For NSCLC spinal metastasis patients with 7-10 of novel survival prediction algorithm.