Complete Mesogastric Excision for Locally Advanced Gastric Cancer: Safety and Efficacy Analysis of a Randomized Clinical Trial

2020 ◽  
Author(s):  
Daxing Xie ◽  
Jie Shen ◽  
Liang Liu ◽  
Beibei Cao ◽  
Yatao Wang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Advanced Gastric Cancer ◽  
Randomized Clinical Trial ◽  
Locally Advanced ◽  
Safety And Efficacy ◽  
Efficacy Analysis ◽  
Locally Advanced Gastric Cancer

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.

Safety and efficacy of neoadjuvant chemotherapy with S-1 and oxaliplatin plus apatinib for locally advanced gastric cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15503-e15503
Author(s):  
Ya'nan Zheng ◽  
Xiao Yang ◽  
Zhentian Ni ◽  
Zhenglun Zhu ◽  
Wei Xu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
R0 Resection ◽  
Resection Rate ◽  
Surgical Morbidity ◽  
Safety And Efficacy ◽  
Locally Advanced Gastric Cancer

e15503 Background: Locally advanced gastric cancer (LAGC) has a poor prognosis. Neoadjuvant chemotherapy can reduce tumor loading, degrade staging and increase possibility of complete resection, thus prolonging the survival of LAGC patients (pts). We conducted a phase II trial to assess the feasibility of SOX regimen in combination with apatinib (an anti-angiogenic agent) as neoadjuvant therapy in LAGC. Methods: This study recruited untreated LAGC pts with pathologically and/or cytologically confirmed adenocarcinoma. Treatment included three 21-day cycles of apatinib (oral, 500 mg qd; discontinued in the last cycle), S-1 (oral, 40-60 mg, bid, day 1-day 14) and oxaliplatin (iv, 130 mg/m2, day 1), followed by radical surgery after 4 weeks. The primary outcome was neoadjuvant therapy related toxicity, and the secondary outcomes included tumor response, R0 resection rate, postoperative pathological evaluation and surgical morbidity. Results: Between December 2, 2016 and August 1, 2018, 31 patients were enrolled. Total 29 patients were eligible for safety and efficacy analyses of SOXA as NAC. During NAC treatment, the incidence of adverse events (AEs, any grade) was 100%, and the incidence of grade 3/4 AEs was 34.48%. No treatment-related death. The ORR of 79.31% (95%CI, 60.28-92.01%) and DCR of 96.55% (95%CI, 82.24-99.91%) were achieved. One patient was evaluated as PD with hepatic metastasis after 3 cycles of preoperative chemotherapy, and this case was inoperable. Resection with curative intent was undertaken in 28 patients with R0 resection rate of 100%. Operative morbidity was observed in 12 of 28 patients including fever (9, 32.14%), anastomotic leakage (1, 3.57%), fat liquefaction of post-surgical incision (1, 3.57%), and gastroparesis (1, 3.57%). Additionally, after surgery 1 patient had pulmonary infection and 1 patient had pleural effusion. The median tumor regression was 90% on pathological findings after surgery. Conclusions: Neoadjuvant therapy with apatinib plus SOX for LAGC showed acceptable toxicity and promising efficacy.

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.

SAMIT: A phase III randomized clinical trial of adjuvant paclitaxel followed by oral fluorinated pyrimidines for locally advanced gastric cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. LBA4002-LBA4002
Author(s):  
Kazuhiro Yoshida ◽  
Akira Tsuburaya ◽  
Michiya Kobayashi ◽  
Shigefumi Yoshino ◽  
Masazumi Takahashi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Phase Iii ◽  
Daily News ◽  
Online Supplement ◽  
Locally Advanced Gastric Cancer ◽  
Fluorinated Pyrimidines ◽  
Final Text

LBA4002 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Monday, June, 3, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News.

CPT-11/Cisplatin neoadjuvant therapy downstages locally advanced gastric cancer

2001 ◽  
Vol 120 (5) ◽  
pp. A129-A129
Author(s):  
E NEWMAN ◽  
S MARCUS ◽  
M POTMESIL ◽  
H HOCHSTER ◽  
H YEE ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Locally Advanced Gastric Cancer
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