Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy

2020 ◽  
Vol 121 (4) ◽  
pp. 662-669 ◽  
Author(s):  
Chul Kyu Roh ◽  
Sang‐Yong Son ◽  
Sook Young Lee ◽  
Hoon Hur ◽  
Sang‐Uk Han
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Clinical Pathway ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Phase Ii Clinical Trial ◽  
Single Center ◽  
Safety And Efficacy

Tu1448 Intragastric Injection of Botulinum Toxin a to Treat Gastric Cancer: An Open-Label Phase II Clinical Trial

2016 ◽  
Vol 150 (4) ◽  
pp. S1251-S1252
Author(s):  
Gøran Andersen ◽  
Chun-Mei Zhao ◽  
Xing Cai ◽  
Hanne-Line Rabben ◽  
James G. Fox ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Botulinum Toxin ◽  
Phase Ii ◽  
Botulinum Toxin A ◽  
Phase Ii Clinical Trial ◽  
Open Label ◽  
Toxin A ◽  
Open Label Phase

Efficacy and safety of liposomal mitoxantrone (Lipo-MIT) in advanced breast cancer (ABC): A randomized, open label, active-controlled, single-center, phase II clinical trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1093-1093
Author(s):  
Leiping Wang ◽  
Yannan Zhao ◽  
Ting Li ◽  
Jun Cao ◽  
Yiqun Du ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Lower Incidence ◽  
Troponin T ◽  
Objective Response ◽  
Phase Ii Clinical Trial ◽  
Efficacy And Safety ◽  
Single Center ◽  
Open Label

1093 Background: Anthracyclines are associated with cardiotoxicity and myelosuppression in breast cancer (BC) patients. A new drug delivery system, liposomal preparation has shown higher anti-cancer effect and lower toxicity due to modified drug release and particle shape. This trial aimed to evaluate the efficacy and safety of Lipo-MIT in ABC. Methods: This is a randomized, open label, active-controlled, single-center, phase II clinical trial. Eligible patients were randomized in a ratio of 1:1 to receive Lipo-MIT or mitoxantrone hydrochloride injection (MIT) intravenously. The dosage was 20 mg/m2 for Lipo-MIT and 14 mg/m2 for MIT, once every four weeks (i.e., one treatment cycle). The primary endpoint was objective response rate(ORR). The secondary endpoints were progression free survival (PFS) and safety. Results: From Oct 2015 through Jul 2017, 60 patients were randomized to Lipo-MIT group (n = 30) or MIT group (n = 30). The Median (Q1,Q3) age was 56.0 (41.0,62.0) years in Lipo-MIT group and 54.5 (44.0,62.0) years in MIT group. Nineteen patients in Lipo-MIT group and 23 in MIT group received < 4 cycles of treatment, 11 patients in Lipo-MIT group and 7 in MIT group were treated for 4 or more cycles. When Lipo-MIT group was compared with MIT group, ORR was 13.3% (4/30) and 6.7% (2/30), disease control rate (PR+SD) was 50% (15/30) and 30% (9/30), median PFS was 2.30 (95% CI: 1.74-3.91) and 1.86 (95% CI: 1.74-2.40) months ( P> 0.05). Lipo-MIT showed significantly lower incidence of all-grade white blood cell decreased (86.7% vs 96.7%), neutrophil count decreased (80.0% vs 96.7%), conjugated bilirubin increased (53.3% vs 56.7%), aspartate aminotransferase increased (40.0% vs 53.3%), and troponin T increased (3.3% vs 36.7%) than MIT, but higher incidence of anemia (76.7% vs 46.7%), skin hyperpigmentation (66.7% vs 3.3%), and platelet count decreased (56.7% vs 53.3%) than MIT. Conclusions: Lipo-MIT provided numerically better ORR, DCR, and PFS than MIT in ABC. Lower incidence of troponin T increased might suggest lower cardiotoxicity of Lipo-MIT. It is worthwhile to further explore the clinical utility of Lipo-MIT in ABC. Clinical trial information: NCT02596373 .

scholarly journals Protocol for enhanced recovery after surgery improves short-term outcomes for patients with gastric cancer: a randomized clinical trial

2017 ◽  
Vol 20 (5) ◽  
pp. 861-871 ◽  
Author(s):  
Ryo Tanaka ◽  
Sang-Woong Lee ◽  
Masaru Kawai ◽  
Keitaro Tashiro ◽  
Satoshi Kawashima ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Short Term
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