Perioperative capecitabine plus oxaliplatin therapy for clinical stage III gastric cancer

Phase 2

• Conditions: Gastric Cancer; C16.9

• Registration Number: JPRN-jRCTs051180109
• Lead Sponsor: GOTO Masahiro

Brief Summary

Perioperative CapeOx showed good feasibility and favorable efficacy with sufficient pathological response, although statistical significance at 0.058 did not reach the commonly accepted cutoff of 0.05. The data obtained using this novel approach warrant further investigations.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-08
• Study Completion: 2020-07-31
• Results First Posted: 2022-04-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 37

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological response rate

Secondary Outcome Measures

Name	Time	Method
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, <br>Response Rate (RR), Incidence of adverse events of neoadjuvant chemotherapy,<br>Incidence of adverse events of adjuvant chemotherapy, Incidence of surgical complications, <br>RDI of adjuvant chemotherapy, RR by gastrointestinal endscopy