Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer

University of Navarra

Status: Completed

Conditions: Gastric Cancer; Surgery; Effects of Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT02454673

CUN-GCNMEM

Details and patient eligibility

About

The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.

Full description

Patients with locally advanced gastroesophageal junction and gastric cancer with T3-4 and/or N+ are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. The neoadjuvant strategy consisted of 3-4 cycles of preoperative chemotherapy (group A) or 3-4 courses of induction chemotherapy followed by concurrent chemoradiotherapy (group B). Chemoradiotherapy comprised 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. Nonlinear mixed effects (NLME) modelling is applied to evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) on the clinical outcome of these patients.

Enrollment: 121 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer
• 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

Trial design

121 participants in 2 patient groups

Group A

Description:

* 3-4 cycles of preoperative chemotherapy * Surgery

Group B

Description:

* 3-4 cycles of induction chemotherapy * Radiotherapy with concurrent chemotherapy for 5 weeks * Surgery