Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients
- Conditions
- AdenocarcinomaSurgeryEffects of ChemotherapyGastric CancerGastrointestinal Neoplasms
- Registration Number
- NCT02454647
- Lead Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival 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 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 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 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 Outcome Measures
Name Time Method Pathological response Week 24 to 28 Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.
Patterns of treatment failure From date of diagnosis until treatment failure, assessed up to 10 years Type of recurrence: local, regional and/or distant.
Adverse events are assessed according to CTC criteria v 4.0 Week 1 to 20 Safety and tolerability during the neoadjuvant protocol.
Trial Locations
- Locations (1)
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain