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

University of Navarra

Status: Completed

Conditions: Gastric Cancer; Surgery; Effects of Chemotherapy; Adenocarcinoma; Gastrointestinal Neoplasms

Treatments: Procedure: Salvage surgery; Radiation: Radiotherapy with concurrent chemotherapy; Drug: Induction chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT02454647

GC-PKPDGN

Details and patient eligibility

About

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.

Full 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)

Enrollment: 46 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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