scholarly journals A PHASE II TRIAL EXPLORING THE EXTENSIVE INTRA-OPERATIVE PERITONEAL LAVAGE (EIPL) AS A PROPHYLACTIC STRATEGY FOR PERITONEAL RECURRENCE IN LOCALLY ADVANCED GASTRIC CANCER: reporting postoperative morbidity and mortality after early closure

2015 ◽  
Vol 52 (2) ◽  
pp. 161-164 ◽  
Author(s):  
Thales Paulo BATISTA ◽  
Mário Rino MARTINS ◽  
Euclides Dias MARTINS-FILHO ◽  
Rogerio Luiz dos SANTOS
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Peritoneal Lavage ◽  
Locally Advanced ◽  
Open Label ◽  
Safety And Efficacy ◽  
Intention To Treat ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients

Background The Extensive Intraoperative Peritoneal Lavage (EIPL) has been proposed as a practical prophylactic strategy to decrease the risk of peritoneal metastasis in gastric cancer. Objective To explore the safety and efficacy of the EIPL in our locally advanced gastric cancer patients. Methods This study is an open-label, double-center, single-arm phase II clinical trial developed at two tertiary hospitals from Recife (Pernambuco, Brazil). Results The study protocol was prematurely closed due to slow accrual after only 16 patients had been recruited to participate. Eight of them were excluded of the protocol study during the laparotomy, whereas four cases were also excluded from the per-protocol analysis. Two patients had died in hospital before 30 days and six were alive with no evidence of cancer relapses after a follow-up ranging from five to 14,2 months (median of 10.6 months). In the intention-to-treat analysis, three of eight patients suffered of gastrointestinal leakages and two of them had died. On a per-protocol basis, two of four patients presented this type of postoperative complication and one of them had died. All deaths occurred as a somewhat consequence of gastrointestinal leakages. Conclusion We could not make any conclusion about the safety and efficacy of the EIPL, but the possibility of this approach might increase the rate of gastrointestinal leakage is highlighted.

scholarly journals Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Birendra Kumar Sah ◽  
Benyan Zhang ◽  
Huan Zhang ◽  
Jian Li ◽  
Fei Yuan ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Group Versus ◽  
Open Label ◽  
Regression Grading ◽  
Locally Advanced Gastric Cancer

AbstractNeoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (FLOT regimen) has shown promising results in terms of pathological response and survival rate in patients with locally advanced resectable gastric cancer (LAGC). However, tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (SOX regimen) is the preferred chemotherapy regimen in Eastern countries. Here, we conduct an open label, two-arm, phase II randomized interventional clinical trial (Dragon III; ClinicalTrials.gov: NCT03636893) to evaluate the safety and efficacy of both regimens. Patients with LAGC are randomly assigned to receive either 4 cycles of the neoadjuvant FLOT regimen (40 patients) or 3 cycles of the SOX regimen (34 patients) before gastrectomy. The primary endpoint is the comparison of complete (TRG1a) or subtotal (TRG1b) tumor regression grading in the primary tumor. There are no significant differences in adverse effects or postoperative morbidity and mortality between the two groups. No significant differences in the proportion of tumor regression grading between the FLOT group and the SOX group are found. Complete or subtotal TRG is 20.0% in the FLOT group versus 32.4% in the SOX group. Therefore, our study does not find statistically significant differences between neoadjuvant FLOT and SOX regimens for the primary outcomes reported here in locally advanced gastric cancer.

scholarly journals FEATURES OF EMERGENCY SURGERY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER

2020 ◽  
pp. 108-112
Author(s):  
V. V. Boyko ◽  
I. V. Krivorotko ◽  
V. A. Lazirsky
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Surgical Intervention ◽  
Locally Advanced ◽  
Postoperative Mortality ◽  
Surgical Interventions ◽  
Second Stage ◽  
Locally Advanced Gastric Cancer ◽  
Surgical Tactics ◽  
Gastric Cancer Patients

Summary. Materials and methods. The work is based on an analysis of the results of surgical treatment of 418 patients with complicated locally advanced gastric cancer. Patients are divided into two groups: comparisons — 212, and the main — 206 patients who were treated from 2006 to 2010. and from 2011 to 2015 respectively. The complications rating was: bleeding in 252 (60.3 %) patients, stenosis in 89 (21.3 %), perforation in 15 (3.5 %), and their combination in 62 (14.8 %). Results and discussion. Radical operations were performed in 212 (50.7 %) patients, in 145 (34.6 %) — palliative and symptomatic. Postoperative complications occurred in 82 patients (19.6 %), postoperative mortality was 7.2 % (30 patients). A two-stage surgical tactics has been developed, which involves the implementation of minimally invasive endoscopic and endovascular surgical interventions at the first stage with the implementation of a delayed or planned surgical intervention at the second stage. Conclusions. Urgent operations decreased from 21.7 to 6.3 %, which reduced the number of palliative and symptomatic operations from 50.4 to 18.4 %.

scholarly journals Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Jing Guo ◽  
Aman Xu ◽  
Xiaowei Sun ◽  
Xuhui Zhao ◽  
Yabin Xia ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Peritoneal Lavage ◽  
Randomized Study ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Disease Recurrence ◽  
Phase Iii ◽  
Free Survival ◽  
Locally Advanced Gastric Cancer

AbstractWhether extensive intraoperative peritoneal lavage (EIPL) after gastrectomy is beneficial to patients with locally advanced gastric cancer (AGC) is not clear. This phase 3, multicenter, parallel-group, prospective randomized study (NCT02745509) recruits patients between April 2016 and November 2017. Eligible patients who had been histologically proven AGC with T3/4NxM0 stage are randomly assigned (1:1) to either surgery alone or surgery plus EIPL. The results of the two groups are analyzed in the intent-to-treat population. A total of 662 patients with AGC (329 patients in the surgery alone group, and 333 in the surgery plus EIPL group) are included in the study. The primary endpoint is 3-year overall survival (OS). The secondary endpoints include 3-year disease free survival (DFS), 3-year peritoneal recurrence-free survival (reported in this manuscript) and 30-day postoperative complication and mortality (previously reported). The trial meets pre-specified endpoints. Estimated 3-year OS rates are 68.5% in the surgery alone group and 70.6% in the surgery plus EIPL group (log-rank p = 0.77). 3-year DFS rates are 61.2% in the surgery alone group and 66.0% in the surgery plus EIPL group (log-rank p = 0.24). The pattern of disease recurrence is similar in the two groups. In conclusion, EIPL does not improve the 3-year survival rate in AGC patients.

scholarly journals Neoadjuvant therapy for locally advanced gastric cancer patients. A population pharmacodynamic modeling

PLoS ONE ◽  
2019 ◽  
Vol 14 (5) ◽  
pp. e0215970 ◽  
Author(s):  
Patricia Martin-Romano ◽  
Belén P. Solans ◽  
David Cano ◽  
Jose Carlos Subtil ◽  
Ana Chopitea ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Locally Advanced ◽  
Pharmacodynamic Modeling ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients
Sign in / Sign up

Export Citation Format

Share Document