Perioperative capecitabine plus oxaliplatin therapy for clinical stage III gastric cancer

JRCT ID: jRCTs051180109

Registered date:08/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 07/07/2016
• Target sample size: 37
• Study type: Interventional

Intervention(s)

1 Preoperative capecitabine(1.000mg/m2 bid day1-14) plus oxaliplatin(130mg/m2 day1) combination therapy every three weeks for three cycles
2 D2 gastrectomy
3 Postoperative apecitabine plus oxaliplatin combination therapy every three weeks for five cycles

Outcome(s)

• Primary Outcome: Pathological response rate

Secondary Outcome

Percent completion (PC) of the protocol treatment, Relative Dose Intensity (RDI) of neoadjuvant chemotherapy, PC of adjuvant chemotherapy,Overall survival, Relapse free survival, Progression free survival,
Response Rate (RR), Incidence of adverse events of neoadjuvant chemotherapy,
Incidence of adverse events of adjuvant chemotherapy, Incidence of surgical complications,
RDI of adjuvant chemotherapy, RR by gastrointestinal endscopy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histological proven adenocarcinoma.
2) cSS/SE N1-3 M0 gastric cancer.
3) Possible oral intake
4) ECOG performance status of 0 or 1.
5) Aged 20 years old or over.
6) Adequate organ function
7)Written informed consent from patient.

Exclude criteria

1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Past history of severe hypersensitivity to drugs.
3) with active infection (a fever over 38 degrees)
4) Pregnant women, or women with the possibility of the pregnancy
5) Men who want let to pregnancy.
6) History of myocardial infarction with 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 (8cm or less) type 3.
13) Patients judged inappropriate for the study by the physicians.

Related Information

• Primary Sponsor: GOTO Masahiro
• Secondary Sponsor: Osaka Clinical Study Supporting Organization
• Secondary ID(s): UMIN000021641