A Randomized Phase II Study to Evaluate Prolonged Prophylactic Antibacterial Drug Treatment for Patients with Elevated Drain Amylase Concentration After Gastrectomy with D2 Lymph Node Dissection (REDUCED2)

2021 ◽  
Author(s):  
Yuichiro Miki ◽  
Masanori Tokunaga ◽  
Keita Mori ◽  
Norimasa Fukushima ◽  
Kazunari Misawa ◽  
...  
Keyword(s):  
Lymph Node ◽  
Drug Treatment ◽  
Lymph Node Dissection ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Antibacterial Drug ◽  
Node Dissection ◽  
D2 Lymph Node Dissection ◽  
Randomized Phase Ii ◽  
Drain Amylase

Final results of a multi-center, double-blind, randomized, placebo-controlled phase II study to assess the efficacy of MAGE-A3 immunotherapeutic as adjuvant therapy in stage IB/II non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7554-7554 ◽  
Author(s):  
J. Vansteenkiste ◽  
M. Zielinski ◽  
A. Linder ◽  
J. Dahabre ◽  
E. Esteban ◽  
...  
Keyword(s):  
Overall Survival ◽  
Lymph Node ◽  
Adjuvant Therapy ◽  
Lymph Node Dissection ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Phase Iii ◽  
Node Dissection ◽  
Stage Ib ◽  
Disease Free

7554 Background: After complete resection, about 50% of patients with stages IB-II NSCLC disease die within 5 years. Adjuvant chemotherapy improves overall survival at the expense of substantial toxicity. Activity of MAGE-A3 immunotherapeutic (i.e. recombinant MAGE-A3 protein and a potent GlaxoSmithKline adjuvant) was previously demonstrated in metastatic melanoma. As about 35% of NSCLCs express MAGE-A3 antigen, post-operative MAGE-treatment may be a tumor-specific, well tolerated, and effective adjuvant therapy. Methods: Patients with completely resected, MAGE-A3 (+), stage pIB or pII were randomly assigned to postoperative MAGE-A3 or placebo (2:1), with 5 administration at 3-week intervals, followed by 8 administrations every 3 months. Randomization was stratified for stage (IB vs. II), histology (squamous vs. other), and lymph-node (LN) procedure (sampling vs. dissection). Primary endpoint was disease-free interval (DFI); other endpoints were safety, disease-free survival (DFS), and overall survival (OS). This exploratory Phase II study was designed to detect a clinically relevant HR with a 10% one-sided a. Results: 182 patients (122 stage IB, 60 stage II) from 59 centers in 14 countries were randomized over 2 years: Median age 63 (45–81); 87% male; 65% squamous cell carcinoma; 65% lymph-node dissection. After a median follow-up of 28 months, 67 recurrences and 45 deaths were recorded. Group comparisons of DFI, DFS and OS gave respectively a hazard ratio (HR) of 0.74 (95% CI 0.44–1.20, p=0.107), 0.73 (95% CI 0.45–1.16) and 0.66 (95% CI 0.36–1.20) in favor of the MAGE-A3 group. Overall, treatment was well tolerated, with excellent protocol compliance. Subset analysis also suggests that LN dissection may have an effect on survival. Conclusions: The final analysis of this randomized phase II study shows a positive trend for activity of MAGE-A3 treatement in NSCLC with a relative improvement of DFI and DFS of 27%. Further phase III evaluation is planned. This study also suggests that complete lymph-node dissection may have an effect on survival and should be confirmed prospectively. [Table: see text]

scholarly journals Phase II Study of Capecitabine Combined With Intensity-Modulated Radiotherapy After D1/D2 Lymph Node Dissection in Patients with Gastric Cancer

2020 ◽  
Author(s):  
Hua Ren ◽  
Xin Wang ◽  
Wei-Hu Wang ◽  
Shu-Lian Wang ◽  
Yong-Wen Song ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Advanced Gastric Cancer ◽  
Lymph Node Dissection ◽  
Phase Ii Study ◽  
Intensity Modulated Radiotherapy ◽  
Node Dissection ◽  
D2 Lymph Node Dissection ◽  
Intensity Modulated ◽  
Local Advanced

Abstract Background: Adjuvant chemoradiotherapy (ACRT) with oral capecitabine and intensity-modulated radiotherapy (IMRT) was well tolerated in a phase I study in patients who had undergone partial or total gastrectomy for locally advanced gastric cancer. This phase II study aimed to further determine the efficacy and toxicity of this combination after radical resection and D1/D2 lymph node dissection (LND) for local advanced gastric patients.Methods: Forty patients (median age, 53 years; range, 24–71 years) with pathologically confirmed adenocarcinoma who underwent D1/D2 LND were included in this study. The patients received ACRT comprising IMRT (total irradiation dose: 45 Gy delivered in daily 1.8-Gy fractions on 5 days a week over 5 weeks) and capecitabine chemotherapy (dose: 800 mg/m² twice daily throughout the duration of RT). The primary study endpoint was disease-free survival (DFS) and the secondary endpoints were overall survival (OS), toxic effects, and treatment compliance.Results: The 3-year DFS and OS were 66.2% and 75%, respectively. The median time to recurrence was 19.5 months (range, 6.1–68 months). Peritoneal implantation (n = 10) was the most common recurrence pattern, and the lung was the most common site of extra-abdominal metastases (n = 5). Nine patients developed grade 3 or 4 toxicities during ACRT. Two patients discontinued ACRT, while 11 underwent ACRT without receiving the entire course of capecitabine. There were no treatment-related deaths.Conclusion: The ACRT protocol described herein showed acceptable safety and efficacy for local advanced gastric cancer received radical gastrectomy and D1/2 LND.Trial registration: ClinicalTrials.gov, NCT01674959. Registered August 2012 - Retrospectively registered, http://www.isrctn.com/ISRCTN12345678

A Phase-II Clinical Trial of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Gastric Cancer Patients

2007 ◽  
Vol 14 (11) ◽  
pp. 3148-3153 ◽  
Author(s):  
Jun Ho Lee ◽  
Young-Woo Kim ◽  
Keun Won Ryu ◽  
Jong Ryul Lee ◽  
Chan Gyoo Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Lymph Node ◽  
Cancer Patients ◽  
Lymph Node Dissection ◽  
Phase Ii ◽  
Distal Gastrectomy ◽  
Node Dissection ◽  
D2 Lymph Node Dissection ◽  
Gastric Cancer Patients

Laparoscopy-assisted distal gastrectomy with systemic lymph node dissection: A phase II study following the learning curve

2005 ◽  
Vol 91 (1) ◽  
pp. 26-32 ◽  
Author(s):  
Michitaka Fujiwara ◽  
Yasuhiro Kodera ◽  
Shinichi Miura ◽  
Yasuaki Kanyama ◽  
Hiroyuki Yokoyama ◽  
...  
Keyword(s):  
Lymph Node ◽  
Learning Curve ◽  
Lymph Node Dissection ◽  
Phase Ii ◽  
Distal Gastrectomy ◽  
Phase Ii Study ◽  
Node Dissection

Đánh giá kết quả phẫu thuật nội soi hoàn toàn và phẫu thuật nội soi hỗ trợ cắt toàn bộ dạ dày nạo vét hạch D2 do ung thư

2021 ◽  
Author(s):  
Van Huong Nguyen
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Total Gastrectomy ◽  
Lymph Node Dissection ◽  
Laparoscopic Total Gastrectomy ◽  
Node Dissection ◽  
Female Ratio ◽  
D2 Lymph Node Dissection ◽  
Totally Laparoscopic Total Gastrectomy ◽  
Totally Laparoscopic

TÓM TẮT Đặt vấn đề: Nghiên cứu nhằm đánh giá kết quả phẫu thuật nội soi hoàn toàn và phẫu thuật nội soi hỗ trợ cắt toàn bộ dạ dày nạo vét hạch D2 do ung thư tại Bệnh viện Hữu nghị Đa khoa Nghệ An. Phương pháp: Nghiên cứu mô tả hồi cứu, gồm 126 bệnh nhân ung thư dạ dày được phẫu thuật nội soi hoàn toàn và phẫu thuật nội soi hỗ trợ cắt toàn bộ dạ dày vét hạch D2, từ 2013 đến 2020 Kết quả: Tuổi trung bình 60,6 ± 11,1 tuổi. Tỷ lệ nam/nữ 2.8/1. Ung thư ở giai đoạn I, II, III là 19,0%, 49,2%, 31,7%. Ung thư biểu mô tuyến nhú và ống là 70,6% và tế bào nhẫn là 24,6%. Tỷ lệ tai biến trong mổ của nhóm PTNS hoàn toàn là 4,4% và PTNS hỗ trợ 20,6%. Số hạch nạo vét được trung bình của 2 nhóm PTNS hoàn toàn là 23,7 ± 7,1 hạch và PTNS hỗ trợ là 18,0 ± 7,2 hạch. Lượng máu mất trung bình của PTNS hoàn toàn 30,56 ± 10,2 ml và PTNS hỗ trợ 36,11 ± 9,9 ml. Thời gian phẫu thuật trung bình của nhóm PTNS hoàn toàn là 206,4 ± 30,6 phút và PTNS hỗ trợ 220 ± 40,9 phút. Tỷ lệ biến chứng sau mổ của nhóm PTNS hoàn toàn là 4,4% và PTNS hỗ trợ là 22,3%. Thời gian nằm viện trung bình của nhóm PTNS hoàn toàn là 7,5 ± 2,1 ngày và PTNS hỗ trợ là 10,2 ± 2,4 ngày. Kết luận: Phẫu thuật nội soi hoàn toàn và phẫu thuật nội soi hỗ trợ cắt toàn bộ dạ dày nạo vét hạch D2 do ung thư là kỹ thuật an toàn và hiệu quả trong điều trị ung thư dạ dày. ABSTRACT EVALUATION OF OUTCOMES TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY AND LAPAROSCOPIC - ASSISTED TOTAL GASTRECTOMY WITH D2 LYMPH NODE DISSECTION DUE TO CANCER Introduction: To evaluate the results of totally laparoscopic total gastrectomy (TLTG) and laparoscopicassisted total gastrectomy (LATG) with D2 lymph node dissection to treat gastric cancer in the Nghean General Friendship Hospital. Materials and Methods: In a retrospective cohort study, 126 patients with gastric cancer underwent TLTG and LATG with D2 lymph node dissection between 2013 and 2020. Results: There were 126 patients with an average age of 60.6 ± 11.1 years. The male/female ratio was 2.8/1. The percent of patients with tumors at stages I, II, III were 19.0%, 49.2%, 31.7%, 70.6% of patients had papillary adenocarcinoma and tubular adenocarcinoma. Patients with ring cell carcinoma wereaccounted for 24.6%. The total percent of incidents during the surgery of the group of TLTG was 4.4%, and the group of LATG was 20.6%. The average number of harvested lymph nodes in the group of TLTG was 23.7 ± 7.1, and the group of LATG was 18.0 ± 7.2. The average blood loss in the group of TLTG was 30.56 ± 10.2 ml, and the group of LATG was 36.11 ± 9.9 ml, and the average operation time in the group of TLTG was 206.4 ± 30.6 minutes, and the group of LATG was 220 ± 40.9 minutes. The total percent of postoperative complications in the group of TLTG was 4.4%, and the group of LATG was 22.3%. The hospital stays in the group of TLTG was 7.5 ± 2.1 days, and the group of LATG was 10.2 ± 2.4 days. Conclusions: TLTG and LATGwith D2 lymph node dissectionwere safe and effective in treating gastric cancer. Keywords: Laparoscopic gastrectomy, gastric cancer, total gastrectomy

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