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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021641

Enrollment

Registered

2016-04-01

Start date

2016-07-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
pathological response rate	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTetsuji Terazawa

Osaka Medical College Hospital Chemotherapy Center

terasawat@poh.osaka-med.ac.jp072-683-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026