scholarly journals Study protocol of a randomized phase III trial of comparing preoperative chemoradiation with preoperative chemotherapy in patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma: PREACT

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Xiaowen Liu ◽  
Jiejie Jin ◽  
Hong Cai ◽  
Hua Huang ◽  
Guangfa Zhao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Preoperative Chemotherapy ◽  
Esophagogastric Junction ◽  
Locally Advanced ◽  
Preoperative Chemoradiation ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Esophagogastric Junction Adenocarcinoma ◽  
Locally Advanced Gastric Cancer

Peri/post-operative chemotherapy of oxaliplatin combined with S-1 (SOX) versus post-operative oxaliplatin with capecitabine (XELOX) in locally advanced gastric cancer: RESOLVE Trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15519-e15519
Author(s):  
Jiafu Ji ◽  
Han Liang ◽  
Yingwei Xue ◽  
Lin Shen ◽  
Yanong Wang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Survival Benefit ◽  
Locally Advanced ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Postoperative Therapy ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients ◽  
Clinical Trial Information

e15519 Background: Peri-operative treatment of locally advanced gastric cancer (LAGC) has always been argued. We aim to compare the survival benefit and safety for SOX as peri-opertative therapy versus SOX or XELOX as postoperative therapy after D2 dissection. Methods: RESOLVE is a phase III trial investigating effects of post-operative SOX and XELOX, and peri-operative SOX on LAGC. RESOLVE is the first RCT investigating different therapeutic timeframes in gastric cancer patients with stratification by Lauren classification. Clinical trials JCOG 0501 and RESOLVE exploring optimal chemotherapy modalities are compared in the table below. Results: The study enrolled the first patient in Aug 2012. By Dec 31, 2016, a total of 1061 patients were recruited. Currently 136 patients have died (arm A: 54; arm B: 44; arm C: 37) and 187 patients are under treatment (arm A: 60; arm B: 61; arm C: 66). Conclusions: The patient recruitment has completed and events of DFS will be achieved in 2 years. Clinical trial information: NCT01534546. [Table: see text]

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.

A single-arm, phase II feasibility study of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy in potentially resectable gastric or gastroesophageal junction adenocarcinoma.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 96-96
Author(s):  
M. Ryu ◽  
Y. Choi ◽  
B. Kim ◽  
Y. Park ◽  
H. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Residual Disease ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Phase Iii ◽  
R0 Resection ◽  
Locally Advanced Gastric Cancer ◽  
Grade 3

96 Background: The aim of this study was to evaluate feasibility and safety of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy in patients with potentially resectable adenocarcinoma of stomach or gastroesophageal junction. Methods: Forty-one patients with clinical stage T3-4N0M0 or T2-4N+M0 determined by CT, endoscopic ultrasonography, and laparoscopy were enrolled between DEC 2008 and MAR 2010. Gastrectomy with D2 lymph node dissection was conducted after 3 cycles of DOS chemotherapy. DOS chemotherapy consists of docetaxel 50 mg/m2 iv (day1), oxaliplatin 100 mg/m2 iv (day1), and S-1 40 mg/m2 po bid (days1-14) at 3 weeks interval. After curative gastrectomy, the patients were given 1 year of adjuvant chemotherapy with S-1 (40 mg/m2 D1-28, every 6 weeks). Results: All patients finished the planned neoadjuvant chemotherapy. Twenty-three (56%) patients achieved a partial response, and the remaining 18 patients had stable disease by CT scan after 3 cycles of DOS chemotherapy. No disease progression was observed during the neoadjuvant chemotherapy. A median 4.7 weeks (range, 4.0-7.6) after the start of the 3rd cycle of DOS chemotherapy, 39 (95%) patients underwent R0 resection with no pathologic residual disease in 4 (10%) patients. Hematologic toxicities were common including grade 4 neutropenia (32%), grade 3 thrombocytopenia (17%), and febrile neutropenia (10%). However, hematologic toxicities were generally transient and manageable. There were no grade 3 or 4 non-hematologic toxicities with frequency > 5% of patients. With all toxicities taken together, 21 (51%) patients experienced grade 3 or 4 toxicities (except grade 3 neutropenia). There was no treatment-related death, and surgical complications included only mild wound problem in 4 (10%) patients. Conclusions: In this study, neoadjuvant DOS chemotherapy could induce a sufficient down-staging and R0 resection of locally advanced gastric cancer with mild and manageable toxicities. A phase III randomized trial is planned for evaluating the benefit of neoadjuvant DOS chemotherapy in patients with locally advanced gastric cancer. [Table: see text]

scholarly journals Perioperative chemotherapy for gastric cancer: the current state

2018 ◽  
Vol 20 (2) ◽  
pp. 56-60
Author(s):  
V K Lyadov ◽  
O A Pardabekova ◽  
M A Lyadova
Keyword(s):  
Gastric Cancer ◽  
Malignant Tumors ◽  
Locally Advanced ◽  
High Rate ◽  
Phase Iii ◽  
Perioperative Chemotherapy ◽  
Phase Iii Trial ◽  
Locally Advanced Gastric Cancer ◽  
Current State ◽  
Resectable Gastric Cancer

Gastric cancer has one of the leading positions in the world in the prevalence and mortality among malignant tumors. The results of surgical treatment of locally advanced gastric cancer remain generally poor due to the high rate of relapse after surgery. Currently, perioperative (pre- and postoperative) chemotherapy in combination with surgery is recommended for patients with stage ≥IB resectable gastric cancer. We analyzed the studies devoted to the problem of choosing the optimal regimen of perioperative chemotherapy in locally advanced and oligometastatic gastric cancer. The highest efficacy was observed in the taxan-containing regimen FLOT which allowed to increase the median overall survival up to 50 months in a randomized controlled phase III trial. The use of perioperative chemotherapy with anti-Her2 therapy, immunotherapy or any other biologic drug remains investigational.

scholarly journals Randomized controlled Phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC)

2020 ◽  
Vol 50 (11) ◽  
pp. 1321-1324
Author(s):  
Yuya Sato ◽  
Takanobu Yamada ◽  
Takaki Yoshikawa ◽  
Ryunosuke Machida ◽  
Junki Mizusawa ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Standard Procedure ◽  
Locally Advanced ◽  
Operation Time ◽  
Phase Iii ◽  
Current Standard ◽  
Phase Iii Trial ◽  
D2 Lymph Node Dissection ◽  
Randomized Controlled

Abstract Gastrectomy with omentectomy and D2 lymph node dissection is the current standard procedure for locally advanced gastric cancer. However, some retrospective studies have reported that omentectomy increased post-operative abdominal complications but provided no survival advantage over omentum preservation. Therefore, we plan a randomized controlled phase III trial to confirm the non-inferiority of omentum preservation compared with omentectomy in patients with cT3 (SS) or cT4a (SE) gastric cancer. A total of 1050 patients will be enrolled from 62 institutions over a period of 6.5 years. The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000036253.

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