Factors Determining the Prognosis in NSCLC Stage IV

• Conditions: NSCLC Stage IV

• Registration Number: NCT04306094
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

This study is a cohort study with patients with advanced NSCLC. Patients will answer questionnaires about symptoms and quality of life and will be submitted to physical and blood tests, and computer tomography. The aim of this study is to estimate prognostic factors predicting survival to 3 months in patients with advanced NSCLC.

Detailed Description

Non-small-cell lung cancer (NSCLC) is currently the neoplasm leading in deaths worldwide and in Brazil. NSCLC has a high incidence, is usually diagnosed in advanced stages and has poor survival rates. The ability to refine the prognosis of a disease has implications at the time of diagnosis and decision about treatment. Clinical and laboratory factors are studied to evaluated the prognosis of diseases. Palliative Prognostic Score (PaP score), Karnofsky Performance Status Scale (KPS), Palliative Prognostic Index (PPI) are applied in patients with many types of solid tumors. The Charlson Score evaluates comorbidities and the attributed risk for presence it. Others predictors of prognostic are cachexia, quality of life, inflammatory factors, sarcopenia. There is a need to improve the ability to estimate the prognosis and to identify the factors responsible to low survival rates in patients with NSCLC diagnosed at advanced stage, also as a tool for a better treatment selection.

This is an observational and prospective study, including patients diagnosed with NSCLC and admitted in ICESP, staged as IV at admission, with no previous systemic treatment and classified as ECOG 2-4. Demographic data, presence of a caregiver, anthropometry, MRC dyspnea scale, KPS, Edmont Symptom Scale, Charlson's Comorbidity Score, PPI and PaP were evaluated in each patient. Evaluation of sarcopenia and cachexia with abdominal CT (Slice-O-Matic, v.5), arm circumference, handgrip strength test and quality of life using EORTC score QLQ C-30 and QLQ-CAX-24 were also evaluated. Significant prognostic factors will be selected by multivariate analysis in a training set estimated as 217 patients.

Study Timeline

• Study Start: 2017-11-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-12
• Last Update Posted: 2020-03-12
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• Advanced stage IVa or IVb NSCLC patients histologically diagnosis.
• Eastern Cooperative Oncology Group Performance status 2 - 4
• Treatment-naive

Exclusion Criteria

• Initiate treatment before initiate
• psychiatric illnesses, except depression
• pregnant or breastfeeding women
• two concomitant neoplasms

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	3 months	to assess overall survival in patients with NSCLC

Trial Locations

Locations (1)

Ana Paula de Souza Borges; 🇧🇷 São Paulo, Brazil