Overview

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

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Criteria
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