Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer

Completed

• Conditions: Surgery; Gastric Cancer; Effects of Chemotherapy

• Registration Number: NCT02454673
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-09
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-26
• Last Update Submitted: 2015-05-26
• Study First Posted: 2015-05-27
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Free Survival	From date of diagnosis until treatment failure, assessed up to 10 years	DFS was defined as the time from diagnosis to the first date of local or distant cancer. Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
Overall Survival	From date of diagnosis until death, assessed up to 10 years	Overall survival was defined as the period from diagnosis until death (from any cause). Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).

Secondary Outcome Measures

Name	Time	Method
Pathological Response at the Time of Surgery	Weeks 10 to 28	Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.
R0 Resection rate at the Time of Surgery	Weeks 10 to 28	The R0 resection rate after 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.
Tumor Regression Grade at the Time of Surgery	Weeks 10 to 28	Estimate of tumor regression grade at the time of surgery according to Becker Criteria: Grade 1a, No residual tumor; Grade 1b, \<10% residual tumor; Grade 2, 10-50% residual tumor; Grade 3, \>50% residual tumor.
Lymph nodes response at the Time of Surgery	Weeks 10 to 28	Participants were assessed for node-negative lymph nodes at the time of surgery according to TNM classification. Node-negative (pN0) participants had no regional lymph node metastasis.
Estimate of TN Change From Baseline to Surgery	Weeks 10 to 28	Estimate of TN change due to neoadjuvant treatment is defined as the estimate of the evidence of downstaging between baseline and surgery

Trial Locations

Locations (1)

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain