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

Clinica Universidad de Navarra, Universidad de Navarra46 enrolled

Overview

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.

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)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gastric Cancer Adenocarcinoma Effects of Chemotherapy Surgery Gastrointestinal Neoplasms

Interventions

Induction chemotherapyDRUG

Radiotherapy with concurrent chemotherapyRADIATION

Salvage surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Overall Survival

Overall was defined as the period from diagnosis until death (from any cause).

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Week 24 to 28

Secondary Outcomes

Pathological response

Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.

Time frame: Week 24 to 28

Patterns of treatment failure

Type of recurrence: local, regional and/or distant.

Time frame: From date of diagnosis until treatment failure, assessed up to 10 years

Adverse events are assessed according to CTC criteria v 4.0

Data from ClinicalTrials.gov

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