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

Phase 2

• Conditions: gastric cancer

• Registration Number: JPRN-jRCTs041180007
• Lead Sponsor: Masuishi Toshiki

Brief Summary

mFOLFOX6 may be tolerable and effective and can be one of the treatment options for advanced gastric cancer with severe peritoneal metastases.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-10
• Study Completion: 2021-04-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 51

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified