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Clinical Trials/NCT05893667
NCT05893667
Completed
Not Applicable

Evaluation of Pretreatment Inflammatory Markers in Predicting Response to nCRT and Prognosis in LARC Patients

Hospital Pedro Hispano0 sites245 target enrollmentJanuary 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Locally Advanced Rectal Cancer
Sponsor
Hospital Pedro Hispano
Enrollment
245
Primary Endpoint
Overall survival Disease-free survival
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis.

Methods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox regression and Kaplan-Meier analysis were performed.

Registry
clinicaltrials.gov
Start Date
January 1, 2010
End Date
May 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Pedro Hispano
Responsible Party
Principal Investigator
Principal Investigator

Marina Morais

Principal Investigator

Hospital Pedro Hispano

Eligibility Criteria

Inclusion Criteria

  • patients diagnosed pathologically with rectal adenocarcinomas, located within 12cm from the anal verge (measured by MRI), clinically staged T3-4 and/or N+ and treated with neoadjuvant chemoradiotherapy (nCRT) followed by radical surgery

Exclusion Criteria

  • evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or "watch and wait" approach and evidence of inflammatory or hematological disorders

Outcomes

Primary Outcomes

Overall survival Disease-free survival

Time Frame: 5 years

Secondary Outcomes

  • Pathological response through Ryan Tumor Regression Grade(at study completion, average of 5 years)

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