A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501A)examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy

Phase 2

• Conditions: Gastric Cancer

• Registration Number: JPRN-UMIN000017550
• Lead Sponsor: Kyushu Study group of Clinical Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

1)A patient who has received a transfusion, blood product, or hematopoietic growth factor such as G-CSF up to 14 days prior to enrollment 2)The patient has severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1) 3)The patient has peripheral neuropathy affecting the sensory nerves (Grade 1 or worse) 4)The patient has an active infection 5)The patient has poorly controlled hypertension 6)The patient has poorly controlled diabetes (patients with controlled diabetes who are receiving insulin treatment are eligible for enrollment) 7)The patient has heart disease that may pose a problem 8)The patient has severe pulmonary disease 9)he patient has a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction 10)The patient has active gastrointestinal tract bleeding requiring repeated transfusions 11)The patient is receiving phenytoin, warfarin potassium,or flucytosine 12)The patient has moderate or more severe fluid accumulation in body cavities,such as pleural effusions and ascites,that continually requires treatment such as drainage 13)The patient has brain metastasis or clinical features suggesting brain metastasis 14)The patient has extensive bone metastasis (as determined by the patient's primary physician) 15)The patient has watery diarrhea (watery stool) (Grade 2 or worse) 16)The patient has active multiple cancers 17)The patient has a history of receiving platinum-based antineoplastic agents (e.g. oxaliplatin and cisplatin) 18)A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner 19)The patient tests positive for HBsAg or antibodies to HCV (Date of testing required) 20)A patient who is deemed to need antiviral therapyb (as of enrollment) for HBV-related hepatitis 21)A lead investigator or the patient's primary physician otherwise deems that participation in this trial is not appropriate for the patient

Study & Design

• Study Type: Interventional
• Study Design: Not specified