A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: POF 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. |
Drug: POF
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.
|
| Active Comparator: CAPOX/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. |
Drug: CAPOX/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.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 to 70 years.
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Histologically proven in gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastatic disease.
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Subjects must be able to take orally.
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R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examined to ensure adequate disease classification.
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Previously untreated except for the initial gastric resection for the primary lesion.
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ECOG performance status ≦ 1.
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Able to start chemotherapy with 42 days after gastrectomy.
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Hgb ≧ 9 g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
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Creatine ≦ upper normal limit (UNL)
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Total bilirubin ≦ 1.5 X UNL
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AST, ALT and ALP ≦ 2.5 x UNL
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Life expectancy estimated than 3 months
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Written informed consent
Exclusion Criteria:
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Active double cancer
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Gastrointestinal bleeding
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Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
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Definite contraindications for the use of corticosteroids
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Any subject judged by the investigator to be unfit for any reason to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rongbo Lin | Fuzhou | China | 350014 |
Sponsors and Collaborators
- Fujian Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FNF 014