Gastric Cancer, Adenocarcinoma, Effects of Chemotherapy, Surgery, Gastrointestinal Neoplasms
Conditions
Keywords
Radiotherapy, Neoadjuvant therapy, Induction chemotherapy, Concurrent chemoradiotherapy, Preoperative factors, Dynamic factors, Prognostic Factor
Brief summary
The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors.
Detailed description
Patients with locally advanced gastric cancer (T3-4 and/or N+) are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy. Chemoradiotherapy comprises 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. Estimate whether R0 resection rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)
Interventions
DRUGInduction chemotherapy
RADIATIONRadiotherapy with concurrent chemotherapy
PROCEDURESalvage surgery
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the stomach * 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 * Tumors involving the esophageal junction, comprising siewert I to III
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of treatment until death, assessed up to 10 years | Overall was defined as the period from diagnosis until death (from any cause). |
| Identification of prognostic factors for overall survival | From date of treatment until death, assessed up to 10 years | Overall was defined as the period from diagnosis until death (from any cause). Correlation between survival and baseline, clinical and treatment characteristics from patients |
| Disease-free survival | From date of diagnosis until progression or death, assessed up to 10 years | Disease-free survival was defined as the time from diagnosis to the first date of local or distant cancer. |
| R0 resection rate | Week 24 to 28 | The R0 resection rate in the patients treated with 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patterns of treatment failure | From date of diagnosis until treatment failure, assessed up to 10 years | Type of recurrence: local, regional and/or distant. |
| Adverse events are assessed according to CTC criteria v 4.0 | Week 1 to 20 | Safety and tolerability during the neoadjuvant protocol. |
| Pathological response | Week 24 to 28 | Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen. |
Countries
Spain
Outcome results
None listed