Unique ID issued by UMIN | UMIN000021641 |
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Receipt number | R000024899 |
Scientific Title | Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601) |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2022/11/06 00:30:37 |
Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Japan |
Gastric Cancer
Gastrointestinal surgery |
Malignancy
NO
Eevaluate the efficacy of perioperative CapeOx therapy in patients with clinical stage III gastric cancer.
Safety,Efficacy
Phase II
pathological response rate
1.Percent completion (PC) of the protocol treatment
2.Relative Dose Intensity (RDI) of neoadjuvant chemotherapy
3.Percent completion of adjuvant chemotherapy
4.Overall survival
5.Relapse free survival
6.Response Rate (RR)
7.Incidence of adverse events on neoadjuvant chemotherapy
8.Incidence of a postoperative complication
9.Relative Dose Intensity(RDI) of adjuvant chemotherapy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Other |
preoperative CapeOx therapy
Capecitabine : 1,000mg/m2 bid, day1-14, q3w
Oxaliplatin : 130mg/m2, day 1, q3w
3 cycle
Surgery
Postoperative CapeOx therapy
Capecitabine : 1,000mg/m2 bid, day1-14, q3w
Oxaliplatin : 130mg/m2, day 1, q3w
5 cycle
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically proven gastric adenocarcinoma
2) Clinically diagnosed cSS/SE N1-3 MO gastric cancer
3) Aged 20 years old or over
4) ECOG performance status of 0 or 1
5) Possible oral intake
6) Adequate organ function
a. neutrophilic count : => 1500/mm3
b. hemoglobin : => 8g/dL
c. platelet : => 100,000/mm3
d. AST, ALT : =< 100 IU/L
e. total bilirubin : =< 2mg/dL
f. creatinine clearance : => 50mL/min
7) Wrriten informed consent from patient
1) With active double cancers
2) Past history of severe hypersensitivity to drugs
3) With active infection
4) Pregnant women, or women with the possibility of the pregnancy
5) Men who want let to pregnancy
6) History of myocardial infarction within 6 months
7) Continuous systemic steroid therapy
8) Under treatment with flucytosine, phenytoin
9) Severe diarrhea
10) Positive HBs antigen
11) Severe complications
12) Bulky lymph node metastasis, Borrmann type 4 or large type 3
13) Patients juged inappropriate for the study by the physicians
37
1st name | |
Middle name | |
Last name | Masahiro Gotou |
Osaka Medical College Hospital
Chemotherapy Center
2-7 Daigaku-machi, Takatsuki City , Osaka, 569-8686
072-683-1211
in2030@poh.osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Tetsuji Terazawa |
Osaka Medical College Hospital
Chemotherapy Center
2-7 Daigaku-cho, Takatsuki, Osaka, 569-8686
072-683-1211
terasawat@poh.osaka-med.ac.jp
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Yakult Honsha Co.,Ltd
Profit organization
NO
大阪医科大学(大阪府)
2016 | Year | 04 | Month | 01 | Day |
https://academic.oup.com/oncolo/article/25/2/119/6443288?login=false#google_vignette
Published
https://academic.oup.com/oncolo/article/25/2/119/6443288?login=false#google_vignette
37
Thirty-seven patients were enrolled in CapeOx. Am R0 resection rate of 78.4%(n=29) and a pathological response rate of 54.1%(n=20,p=0.058; 90% confidence interval[CI],39.4-68.2)were demonstrated. among 27 patients who initiated five cycles of adjuvant CapeOx, 21(63.6%) completed the treatment.
2022 | Year | 11 | Month | 06 | Day |
2019 | Year | 09 | Month | 30 | Day |
clinical T3(SS)/T4a(SE) N1-3 M0 GC according to the Japanese Classification of Gastric Carcinoma-3rd English Edition (JCGC)
Thirty-seven pts were enrolled from July 2016 to May 2017.
grade 4 neutropenia
grade 2 anorexia and fatigue
grade 2 allergic reaction
nausea and vomiting
Primary endpoint: Pathological response rate
Secondary endpoint:
The 3-year recurrence-free survival rate
Percentage completion of the protocol treatment
Relative dose intensity(RDI) of neoadjuvant chemotherapy
RDI of adjuvant chemotherapy
The 3-year overall survival rate
Percentage completion of adjuvant chemotherapy
Overall response rate
Safety
Surgical complications
Completed
2016 | Year | 02 | Month | 05 | Day |
2016 | Year | 03 | Month | 07 | Day |
2016 | Year | 07 | Month | 07 | Day |
2020 | Year | 07 | Month | 04 | Day |
2020 | Year | 09 | Month | 28 | Day |
2016 | Year | 03 | Month | 27 | Day |
2022 | Year | 11 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024899
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