Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Overall Survival
Study Overview
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)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Overall Survival
Time Frame: From date of treatment until death, assessed up to 10 years
Overall was defined as the period from diagnosis until death (from any cause).
Disease-free survival
Time Frame: From date of diagnosis until progression or death, assessed up to 10 years
Disease-free survival was defined as the time from diagnosis to the first date of local or distant cancer.
R0 resection rate
Time Frame: Week 24 to 28
The R0 resection rate in the patients treated with 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.
Identification of prognostic factors for overall survival
Time Frame: From date of treatment until death, assessed up to 10 years
Overall was defined as the period from diagnosis until death (from any cause). Correlation between survival and baseline, clinical and treatment characteristics from patients
Secondary Outcomes
- Pathological response(Week 24 to 28)
- Patterns of treatment failure(From date of diagnosis until treatment failure, assessed up to 10 years)
- Adverse events are assessed according to CTC criteria v 4.0(Week 1 to 20)