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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.
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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction chemotherapy | Drug | |||
| Radiotherapy with concurrent chemotherapy | Radiation | |||
| Salvage surgery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patterns of treatment failure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with locally advanced adenocarcinoma of the stomach treated with a neoadjuvant protocol consisting of induction chemotherapy (ICT), chemoradiotherapy (CRT)and salvage surgery. Patients must have a medically fit condition to complete the protocol.
Initial staging comprises a thoracic and abdominal computerised tomography scan, endoscopic ultrasound endoscopy (EUS), biopsy and blood test including blood cell count, hepatic and renal function.
Radiological and endoscopic evaluations are performed at baseline and at the completion of ICT and CRT.
Blood tests are acquired at baseline, before each chemotherapy course and concurrently with evaluations. Blood tests are also obtained during follow-up and at the time progression.
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| Name | Affiliation | Role |
|---|---|---|
| javier Rodriguez Rodriguez, MD, PhD | CUN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
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Surgical specimen with potential for extraction of DNA.
Type of recurrence: local, regional and/or distant.
| From date of diagnosis until treatment failure, assessed up to 10 years |
| Adverse events are assessed according to CTC criteria v 4.0 | Safety and tolerability during the neoadjuvant protocol. | Week 1 to 20 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D000230 | Adenocarcinoma |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D060828 | Induction Chemotherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
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