Effects of Chemotherapy, Gastric Cancer, Surgery
Conditions
Keywords
Radiotherapy, Neoadjuvant therapy, Pharmacodynamics, Pharmacokinetics, Nonlinear Dynamics
Brief summary
The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.
Detailed description
Patients with locally advanced gastroesophageal junction and gastric cancer with T3-4 and/or N+ are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. The neoadjuvant strategy consisted of 3-4 cycles of preoperative chemotherapy (group A) or 3-4 courses of induction chemotherapy followed by concurrent chemoradiotherapy (group B). Chemoradiotherapy comprised weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20. Nonlinear mixed effects (NLME) modelling is applied to evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) on the clinical outcome of these patients.
Interventions
None listed
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer * Age ≥18 years old * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 * Body mass index ≥ 18 * No prior chemotherapy or chemoradiotherapy * TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT) * No evidence of metastasis (M0) * Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)
Exclusion criteria
* Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated * Patients with evidence of severe or uncontrolled systemic disease * Medically unfit for chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Regression Grade at the Time of Surgery | 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. |
| Pathological Response at the Time of Surgery | Weeks 10 to 28 | Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen. |
| Estimate of TN Change From Baseline to Surgery | 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 |
| Lymph nodes response at the Time of Surgery | 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. |
| R0 Resection rate at the Time of Surgery | 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. |
Countries
Spain
Outcome results
None listed