Gastric Cancer Stage III
Conditions
Brief summary
FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).
Interventions
DRUGPOF
A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.
DRUGCAPOX/SOX/FOLFOX
CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles. SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days for 8 cycles. mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years. * Histologically proven in gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastatic disease. * Subjects must be able to take orally. * R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examined to ensure adequate disease classification. * Previously untreated except for the initial gastric resection for the primary lesion. * ECOG performance status ≦ 1. * Able to start chemotherapy with 42 days after gastrectomy. * Hgb ≧ 9 g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3 * Creatine ≦ upper normal limit (UNL) * Total bilirubin ≦ 1.5 X UNL * AST, ALT and ALP ≦ 2.5 x UNL * Life expectancy estimated than 3 months * Written informed consent
Exclusion criteria
* Active double cancer * Gastrointestinal bleeding * Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant * Definite contraindications for the use of corticosteroids * Any subject judged by the investigator to be unfit for any reason to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival | From enrollment to 5 years after treatment | The time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | From enrollment to 5 years after treatment | The time from the date of randomisation to date of death from any cause |
| safety (The incidence of chemotherapy related adverse events) | From enrollment to 1 years after treatment | The incidence of chemotherapy related adverse events |
Countries
China
Contacts
Primary ContactRongbo Lin
Outcome results
None listed