The aim of this study was to compare the efficacy and safety of POF, FOLFOX, and FOLFOX plus paclitaxel(ip) as first-line treatment in AGC a phase II clinical trial.
The biweekly 5-fluorouracil and leucovorin (LV5FU2) regimen associated with oxaliplatin (FOLFOX) is active in patients with AGC. Meanwhile, Paclitaxel monotherapy is also active in patients with AGC. In previous studies, we found that POF(A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. This study is being done to find out if three drugs combination maintain manageable side effects but have better benefit than two drugs combination. Intraperitoneal paclitaxel showed high local concentration in abdominal cavity and low systemic toxicity. This study is being done to find out if the combination with Intraperitoneal paclitaxel and FOLFOX have higher local control rate and lower systemic toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Rongbo Lin
Fuzhou, Fujian, China
Progression-Free Survival,PFS
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
Time frame: 9 month
Response Rate, RR
Response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 9 month
Adverse Event(AE)
Clinical response of treatment according to RESIST v1.1 criteria (ORR, According to NCI CTCAE 4.03 criteria
Time frame: 6month
The EORTC Core Quality of Life questionnaire (QLQ-C30):
a quality-of-life instrument for use in international clinical trials in oncology.
Time frame: 6month
EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy,QLQ-CIPN20
EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy
Time frame: 6 month
Overall Survival(OS)
The length of time from enrollment until the time of death (OS, overall survival
Time frame: 12 months
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