Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer
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|ClinicalTrials.gov Identifier: NCT02454673|
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : May 27, 2015
|Condition or disease|
|Gastric Cancer Effects of Chemotherapy Surgery|
|Study Type :||Observational|
|Actual Enrollment :||121 participants|
|Official Title:||Approximation to the Therapeutic Individualization in Patients With Locally Advanced Gastric and Gastroesophageal Cancer Through Modelling and Generation of Predictive Gene Signatures|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
- Overall Survival [ Time Frame: From date of diagnosis until death, assessed up to 10 years ]Overall survival was defined as the period from diagnosis until death (from any cause). Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
- Disease Free Survival [ Time Frame: From date of diagnosis until treatment failure, assessed up to 10 years ]DFS was defined as the time from diagnosis to the first date of local or distant cancer. Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
- Pathological Response at the Time of Surgery [ Time Frame: Weeks 10 to 28 ]Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.
- R0 Resection rate at the Time of Surgery [ Time Frame: Weeks 10 to 28 ]The R0 resection rate after the neoadjuvant protocol. R0 is defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
- Tumor Regression Grade at the Time of Surgery [ Time Frame: Weeks 10 to 28 ]Estimate of tumor regression grade at the time of surgery according to Becker Criteria: Grade 1a, No residual tumor; Grade 1b, <10% residual tumor; Grade 2, 10-50% residual tumor; Grade 3, >50% residual tumor.
- Lymph nodes response at the Time of Surgery [ Time Frame: Weeks 10 to 28 ]Participants were assessed for node-negative lymph nodes at the time of surgery according to TNM classification. Node-negative (pN0) participants had no regional lymph node metastasis.
- Estimate of TN Change From Baseline to Surgery [ Time Frame: Weeks 10 to 28 ]Estimate of TN change due to neoadjuvant treatment is defined as the estimate of the evidence of downstaging between baseline and surgery
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454673
|Clinica Universidad de Navarra|
|Pamplona, Navarra, Spain, 31008|
|Principal Investigator:||Javier Rodriguez Rodriguez, MD, PhD||Clinica Universidad de Navarra|