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

NCT ID: NCT02454647

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-03-31

Brief 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.

Detailed 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)

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Induction chemotherapy

Intervention Type: DRUG

Radiotherapy with concurrent chemotherapy

Intervention Type: RADIATION

Salvage surgery

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

javier Rodriguez Rodriguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CUN

Locations

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

GC-PKPDGN

Identifier Type: -

Identifier Source: org_study_id