A phase II study of mFOLFOX6 in gastric cancer with severe peritoneal metastasis

A phase II study of mFOLFOX6 as first-line treatment in gastric cancer with severe peritoneal metastasis - WJOG10517G

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041180007

Enrollment

Registered

2018-10-10

Start date

2018-11-02

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

mFOLFOX6 oxaliplatin:85mg/m2 Day1 levofolinate:200 mg/m2 Day1 bolus fluorouracil:400 mg/m2 Day1 continuous infusional fluorouracil: 2400 mg/m2 Day1-3(46 hours)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Written informed consent 2) Between the ages of 20 and 75 3) Histologically confirmed adenocarcinoma 4) HER2 untested or unanalyzable or negative in case of tested 5) Unresectable or recurrent gastric cancer with peritoneal metastasis 6) Patients with symptomatic brain or spinal code metastasis or meningeal dissemination 7) No pleural effusion needed to be removed 8) No fistula between tumor and other organ 9) Measurable or non-measurable disease 10) No previous chemotherapy for gastric cancer 11) No prior use of oxaliplatin 12) 1. Patients with PS 0-2 who have massive ascites or inadequate oral intake. 2.Patients with PS 0-1 who have massive ascites and inadequate oral intake. 13) Adequate organ function

Exclusion criteria

Exclusion criteria: 1) Patients with synchronous or metachronous multiple primary cancer with a disease-free period of =< 3 years at registration. 2) Patients with infection which should be treated 3) Psychiatric disease that is inappropriate for entry into this study 4) History of any medical condition as follows (i)renal insufficiency (ii)liver insufficiency (iii)interstitial pneumonitis (iv)myocardial infarction within the last 6 months or unstable angina pectoris within the last 3 weeks (v)HBs Ag: positive (vi)Grade2 or more peripheral sensory neuropathy (vii)Severe complication which investigators judge 5) Continuous systemic steroids 6) Severe hypersensitivity 7) Pregnant of lactating female 8) Patients who investigators judge inappropriate

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Adverse events Dose intensity Response rate Disease control rate 8 week-time to treatment failure Time to treatment failure Progression-free survival Ascites response rate Ascites disease control rate Overall survival without abdominal paracentesis Rate of improvement of oral intake	—

Contacts

Public ContactToshiki Masuishi

Aichi Cancer Center

tmasuishi@aichi-cc.jp+81-52-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Aug 29, 2026