Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients

Study Overview
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Brief Summary
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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
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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)

Official Title
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Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.

Conditions
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Gastric Cancer, Adenocarcinoma, Effects of Chemotherapy, Surgery, Gastrointestinal Neoplasms

Intervention / Treatment
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* Drug: Induction chemotherapy
* Radiation: Radiotherapy with concurrent chemotherapy
* Procedure: Salvage surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Induction chemotherapy|nan|
|Radiation: Radiotherapy with concurrent chemotherapy|nan|
|Procedure: Salvage surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall was defined as the period from diagnosis until death (from any cause). | From date of treatment until death, assessed up to 10 years | 
| Identification of prognostic factors for overall survival | Overall was defined as the period from diagnosis until death (from any cause). Correlation between survival and baseline, clinical and treatment characteristics from patients | From date of treatment until death, assessed up to 10 years | 
| Disease-free survival | Disease-free survival was defined as the time from diagnosis to the first date of local or distant cancer. | From date of diagnosis until progression or death, assessed up to 10 years | 
| R0 resection rate | 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. | Week 24 to 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological response | Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen. | Week 24 to 28 | 
| Patterns of treatment failure | Type of recurrence: local, regional and/or distant. | From date of diagnosis until treatment failure, assessed up to 10 years | 
| Adverse events are assessed according to CTC criteria v 4.0 | Safety and tolerability during the neoadjuvant protocol. | Week 1 to 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Neoadjuvant therapy, Induction chemotherapy, Concurrent chemoradiotherapy, Preoperative factors, Dynamic factors, Prognostic Factor