JRCT ID: jRCTs041180007
Registered date:10/10/2018
A phase II study of mFOLFOX6 in gastric cancer with severe peritoneal metastasis
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | gastric cancer |
Date of first enrollment | 02/11/2018 |
Target sample size | 50 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 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) |
Outcome(s)
Primary Outcome | Overall survival |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 75age old |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Masuishi Toshiki |
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Secondary Sponsor | Nakagawa Kazuhiko,West Japan Oncology Group |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Toshiki Masuishi |
Address | 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi Aichi Japan 464-8681 |
Telephone | +81-52-762-6111 |
tmasuishi@aichi-cc.jp | |
Affiliation | Aichi Cancer Center |
Scientific contact | |
Name | Toshiki Masuishi |
Address | 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi Aichi Japan 464-8681 |
Telephone | +81-52-762-6111 |
tmasuishi@aichi-cc.jp | |
Affiliation | Aichi Cancer Center |