A dandomized phase ll study consisting S-1 + CDDP (SP) and Capecitabin + CDDP (XP) for adversed/metastatic gastric cancer with mesurable lesions and HER2 negative tumor (HERBIS-4A) (OGSG 1105)

Conditions

Gastric Cancer

Nishikawa K, Kawakami H, Shimokawa T, Fujitani K, Tamura S, Endo S, Kobayashi M, Kawada J, Kurokawa Y, Tsuburaya A, Yoshikawa T, Sakamoto J, Satoh T, for HERBIS-2, HERBIS-4A, XParTS I. I. study investigators.

2023-08-271 citations

10.1007/s10147-023-02402-1

Comparing five-weekly S-1 plus cisplatin with tri-weekly capecitabine plus cisplatin in patients with HER2-negative recurrent gastric cancer after S-1 adjuvant therapy or chemotherapy naïve advanced gastric cancer: A pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials.

Jin Matsuyama, Hisato Kawakami, Kazumasa Fujitani, Yusuke Akamaru, Shigeyuki Tamura et al. (16 authors)

Journal of Clinical Oncology2020-02-01

10.1200/jco.2020.38.4_suppl.379

Randomized, open-label, phase II study comparing five-weekly S-1 plus cisplatin (SP) with tri-weekly capecitabine plus cisplatin (XP) in chemotherapy-naïve patients with HER2 negative advanced gastric cancer (AGC): OGSG 1105 HERBIS-4A trial.

Atsushi Takeno, Youichi Makari, Shunji Endo, Jin Matsuyama, Ryohei Kawabata et al. (20 authors)

Journal of Clinical Oncology2018-02-01

10.1200/jco.2018.36.4_suppl.102

Interventions

S-1+CDDP (SP) Day1 to 21:S-1 take orally(twicw a day) Day8:CDDP 60mg/m2 Drip infusion Day22 to 35:14 days rest S-1+CDDP Day1 to 14:Capecitabin take orally(twicw a day) Day1 CDDP:Drip infusion Da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)proven gastric adenocarcinoma R0 unresectable and HER2 negative histologically, or reccurent gastric cancer not undergo postoperative adjuvant chemotherapy 2)with mesurable lesions 3)patients between 20 and 75 years old 4)PS(ECOG) between 0 and 2 5)patients who not undergo chemotherapy and/or radiation therapy 6)with a good condition of important organs recent 14 days a)WBC:>=3,000/mm3 b)neutrophil>=1,500/mm3 c)platelet>=100,000/mm3 d)hemoglobin>=8.0g/dl e)total bilirubin<=1.5mg/dl f)AST(GOT)<=100IU/L (with hepatic metastasis <=150) g)ALT(GPT)<=100IU/L (with hepatic metastasis <=150) h)serum creatinine<=1.2mg/dl i)creatinin clearance>=60ml/min 7)expected survival longer than 3 months 8)patients who can take orally 9)written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1)with prior chemotherapy and/or radiation therapy 2)with active double cancer(*) *simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years. Carcinoma in situ or Cancers localized in membranous layer are not included to double cancer. 3)with symptoms of brain metastasis 4)with history of severe allergy against medicines 5)with following diseases a)uncontrolled DM b)uncontrolled high-blood pressure c)liver cirrhosis and/or liver failure d)renal failure e)interstitial pneumonitis, pulmonary fibrosis, severe athelectasis f)active infection diseases g)heart failure, cardic infarction and/or severe disorder on ECG during recent 6 months 6)HBs positive status 7)with severe diarrhea (watery stool over 4 times a day) 8)patients who have flucytosine, fenitoin or walfarin 9)patients who have steroids continuously 10)women pregnant or women who like to be pregnant or males who like to have their own baby 11)patients decided not to register to this study due to psychologic diseases and/or psychological symptoms 12)patients whom doctor decide not ro register to this study

Design outcomes

Primary

Measure	Time frame
Response rate (RR)	—

Secondary

Measure	Time frame
Progression-free survival(PFS) Overall survival (OS) Time to treatment failure (TTF) Incidence of adverse evnts	—

Countries

Japan

Contacts

Public ContactHiroshi Furukawa

Kinki University School of Medicine Department of surgery

hiroshi.furukawa@tokushukai.jp072-366-0221

Outcome results

None listed