Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy
Abstract Background Oxaliplatin + S-1 is a recognized treatment regimen in Japan, but there are no Japanese clinical data on an oxaliplatin dose of 130 mg/m2. The current research involves a single-arm, prospective, phase II clinical trial to examine the efficacy and safety of oxaliplatin + S-1 with...
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doaj-cf2a039747f043699b3ba915d3e422a42020-11-25T02:52:55ZengBMCBMC Cancer1471-24072018-01-011811710.1186/s12885-017-3937-6Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapyHiroshi Saeki0Yasunori Emi1Eiji Oki2Shoji Tokunaga3Yoshihiro Kakeji4Yoshito Akagi5Hideo Baba6Eishi Baba7Yoshihiko Maehara8Kyushu Study group of Clinical Cancer (KSCC)Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu UniversityDepartment of Surgery, Saiseikai Fukuoka General HospitalDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu UniversityMedical Information Center, Kyushu University HospitalDivision of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe UniversityDepartment of Surgery, Kurume University School of MedicineDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto UniversityDepartment of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu UniversityDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu UniversityAbstract Background Oxaliplatin + S-1 is a recognized treatment regimen in Japan, but there are no Japanese clinical data on an oxaliplatin dose of 130 mg/m2. The current research involves a single-arm, prospective, phase II clinical trial to examine the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg/m2 to treat HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy in Japan. Methods/design The primary endpoint of this trial will be the response rate, and the secondary endpoints will be the safety profile of oxaliplatin + S-1, progression-free survival, the response rate in subjects under the age of 75, overall survival, time to treatment failure, duration of treatment, time to failure of strategy, and dose intensity. The threshold response rate is 45% and the expected response rate is 60%. Assuming that a one-tailed score test will be performed with an α of 0.05, 68 patients are needed to ensure a statistical power of 80%. Planned enrollment is 70 subjects and the total duration of this trial is expected to be 3 years. Discussion Since replacing cisplatin with oxaliplatin should provide the same level of therapeutic efficacy while limiting adverse events and simplifying treatment, oxaliplatin + S-1 may be increasingly used to treat gastric cancer in Japan. Verifying the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg is an important task that the current trial has set out to achieve. Trial registration The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID UMIN000017550) on May 29, 2015. The details are available at the following web address: http://www.umin.ac.jp/ctr/ .http://link.springer.com/article/10.1186/s12885-017-3937-6Metastatic gastric cancerFirst-line chemotherapyOxaliplatinS-1Japanese patients |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Hiroshi Saeki Yasunori Emi Eiji Oki Shoji Tokunaga Yoshihiro Kakeji Yoshito Akagi Hideo Baba Eishi Baba Yoshihiko Maehara Kyushu Study group of Clinical Cancer (KSCC) |
spellingShingle |
Hiroshi Saeki Yasunori Emi Eiji Oki Shoji Tokunaga Yoshihiro Kakeji Yoshito Akagi Hideo Baba Eishi Baba Yoshihiko Maehara Kyushu Study group of Clinical Cancer (KSCC) Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy BMC Cancer Metastatic gastric cancer First-line chemotherapy Oxaliplatin S-1 Japanese patients |
author_facet |
Hiroshi Saeki Yasunori Emi Eiji Oki Shoji Tokunaga Yoshihiro Kakeji Yoshito Akagi Hideo Baba Eishi Baba Yoshihiko Maehara Kyushu Study group of Clinical Cancer (KSCC) |
author_sort |
Hiroshi Saeki |
title |
Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy |
title_short |
Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy |
title_full |
Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy |
title_fullStr |
Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy |
title_full_unstemmed |
Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy |
title_sort |
study protocol of a phase ii clinical trial (kscc1501a) examining oxaliplatin + s-1 for treatment of her2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2018-01-01 |
description |
Abstract Background Oxaliplatin + S-1 is a recognized treatment regimen in Japan, but there are no Japanese clinical data on an oxaliplatin dose of 130 mg/m2. The current research involves a single-arm, prospective, phase II clinical trial to examine the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg/m2 to treat HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy in Japan. Methods/design The primary endpoint of this trial will be the response rate, and the secondary endpoints will be the safety profile of oxaliplatin + S-1, progression-free survival, the response rate in subjects under the age of 75, overall survival, time to treatment failure, duration of treatment, time to failure of strategy, and dose intensity. The threshold response rate is 45% and the expected response rate is 60%. Assuming that a one-tailed score test will be performed with an α of 0.05, 68 patients are needed to ensure a statistical power of 80%. Planned enrollment is 70 subjects and the total duration of this trial is expected to be 3 years. Discussion Since replacing cisplatin with oxaliplatin should provide the same level of therapeutic efficacy while limiting adverse events and simplifying treatment, oxaliplatin + S-1 may be increasingly used to treat gastric cancer in Japan. Verifying the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg is an important task that the current trial has set out to achieve. Trial registration The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID UMIN000017550) on May 29, 2015. The details are available at the following web address: http://www.umin.ac.jp/ctr/ . |
topic |
Metastatic gastric cancer First-line chemotherapy Oxaliplatin S-1 Japanese patients |
url |
http://link.springer.com/article/10.1186/s12885-017-3937-6 |
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