A randomized phase II trial of docetaxel plus S-1 versus docetaxel plus cisplatin in advanced gastric cancer as a first-line treatment

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 4534-4534 ◽  
Author(s):  
H. Jeung ◽  
C. Im ◽  
S. Rha ◽  
J. Ahn ◽  
S. Shin ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Line Treatment ◽  
First Line ◽  
Randomized Phase Ii ◽  
First Line Treatment

A randomized phase II trial of capecitabine plus cisplatin (XP) versus S-1 plus cisplatin (SP) as a first-line treatment for advanced gastric cancer: XP ascertainment versus SP randomized PII trial (XParTS II).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 105-105 ◽  
Author(s):  
Michiya Kobayashi ◽  
Akira Tsuburaya ◽  
Kazuhiro Nishikawa ◽  
Junji Kawada ◽  
Tsutomu Namikawa ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Group Analysis ◽  
Line Treatment ◽  
First Line ◽  
Cancer Subtypes ◽  
Randomized Phase Ii ◽  
First Line Treatment

105 Background: Capecitabine plus cisplatin (XP) is a standard global regimen for first-line treatment of advanced gastric cancer, however its efficacy compared to S-1 plus cisplatin (SP), a standard treatment in Japan has not been reported. To evaluate the efficacy of XP treatment, we conducted a multicenter randomized phase II trial comparing XP with SP for patients with advanced gastric cancer (ClinicalTrials.gov Identifier NCT0140624). Methods: Patients with unresectable metastatic or recurrent gastric cancer, 20–74 years of age and HER2-negative, were assigned to receive either S-1 40 mg/m2 bid for 21 days plus cisplatin 60 mg/m2 (day 8) every 5-week cycle or capecitabine 1000 mg/m2 bid for 14 days plus cisplatin 80 mg/m2 (day 1) every 3-week cycle. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), time to treatment failure, overall response rate (ORR) and safety. Planned sample size was 100 (50 in each arm) according to PFS at 24-weeks. Immunohistochemical evaluation of biomarkers was also implemented. Results: From November 2011 to June 2013, 116 patients were randomized: median age, 65 years; 79 (68%) male; 63 intestinal and 53 diffuse cancer subtypes. In 109 eligible patients, 24-week %PFS was higher in both groups than the protocol-specified threshold of 40%. Median PFS for SP vs. XP was 25 weeks vs. 23 weeks (HR, 0.76; 95%CI, 0.5-1.16; p=0.203); OS was 58 weeks vs. 56 weeks (HR, 0.90; 95%CI, 0.52-1.57; p=0.712); and ORR was 27.5% vs. 32.7% (p=0.562), respectively. Sub-group analysis by histological classification showed that SP gave better PFS than XP in the diffuse type (HR, 0.42; 95%CI, 0.20-0.86; p=0.015) with no other statistical difference. Most common grade ≥3 adverse events with SP and XP were anemia (16%/ 19%), neutropenia (9%/17%), anorexia (18%/13%), diarrhea (11%/0%), nausea or vomiting (11%/15%), fatigue (5%/6%) and hyponatremia (7%/13%), respectively. Conclusions: XP and SP are comparable and can be recommended as 1st line treatments for advanced gastric cancer. Further analysis for biomarkers related to histology is warranted. Clinical trial information: NCT0140624.

Randomized phase II trial of S-1 plus irinotecan versus S-1 plus paclitaxel as first-line treatment for advanced gastric cancer (OGSG0402): Final report.

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 4015-4015 ◽  
Author(s):  
T. Kishimoto ◽  
H. Imamura ◽  
F. Uedou ◽  
K. Fujitani ◽  
S. Iijima ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Final Report ◽  
Line Treatment ◽  
First Line ◽  
Randomized Phase Ii ◽  
First Line Treatment

Pazopanib and 5-FU/oxaliplatin as first-line treatment in advanced gastric cancer: PaFLO, a randomized phase II study from the AIO (Arbeitsgemeinschaft Internistische Onkologie).

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 4033-4033 ◽  
Author(s):  
Peter C. Thuss-Patience ◽  
Salah-Eddin Al-Batran ◽  
Jens T Siveke ◽  
Nils Homann ◽  
Peter Malfertheiner ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Line Treatment ◽  
First Line ◽  
Randomized Phase Ii ◽  
First Line Treatment

Randomized phase II study comparing paclitaxel with S-1 vs. S-1 as first-line treatment in patients with advanced gastric cancer

2013 ◽  
Vol 15 (10) ◽  
pp. 836-842 ◽  
Author(s):  
X. Wang ◽  
M. L. Wang ◽  
L. Y. Zhou ◽  
X. Y. Lu ◽  
J. F. Yang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Line Treatment ◽  
First Line ◽  
Randomized Phase Ii ◽  
First Line Treatment

Phase II Trial of XELOX as First-Line Treatment for Patients with Advanced Gastric Cancer

Chemotherapy ◽  
2010 ◽  
Vol 56 (2) ◽  
pp. 94-100 ◽  
Author(s):  
Hui-yan Luo ◽  
Rui-hua Xu ◽  
Feng Wang ◽  
Miao-zhen Qiu ◽  
Yu-hong Li ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

6560 Phase II trial of S-1 for elderly patients (pts) over 75 years with advanced gastric cancer as first-line treatment (OGSG0404)

2009 ◽  
Vol 7 (2) ◽  
pp. 378 ◽  
Author(s):  
M. Gotoh ◽  
H. Imamura ◽  
H. Takiuchi ◽  
Y. Kimura ◽  
T. Morimoto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Elderly Patients ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Phase II trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) as first-line treatment for advanced gastric cancer

2009 ◽  
Vol 20 (4) ◽  
pp. 287-293 ◽  
Author(s):  
Weiguo Cao ◽  
Weiping Yang ◽  
Guying Lou ◽  
Jinsong Jiang ◽  
Mei Geng ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment
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