Surgery Clinical Trial
Official title:
Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Spain | Clinica Universidad de Navarra | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Clinica Universidad de Navarra, Universidad de Navarra |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Overall was defined as the period from diagnosis until death (from any cause). | From date of treatment until death, assessed up to 10 years | No |
Primary | Identification of prognostic factors for overall survival | Overall was defined as the period from diagnosis until death (from any cause). Correlation between survival and baseline, clinical and treatment characteristics from patients | From date of treatment until death, assessed up to 10 years | No |
Primary | Disease-free survival | Disease-free survival was defined as the time from diagnosis to the first date of local or distant cancer. | From date of diagnosis until progression or death, assessed up to 10 years | No |
Primary | R0 resection rate | 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. | Week 24 to 28 | No |
Secondary | Pathological response | Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen. | Week 24 to 28 | No |
Secondary | Patterns of treatment failure | Type of recurrence: local, regional and/or distant. | From date of diagnosis until treatment failure, assessed up to 10 years | No |
Secondary | Adverse events are assessed according to CTC criteria v 4.0 | Safety and tolerability during the neoadjuvant protocol. | Week 1 to 20 | Yes |
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