A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

Phase 3

• Conditions: Gastric Cancer Stage III
• Interventions: Drug: POF; Drug: CAPOX/SOX/FOLFOX

• Registration Number: NCT03788226
• Lead Sponsor: Fujian Cancer Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-27
• Study Start: 2019-02-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-10-13
• Last Update Posted: 2019-10-16
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POF	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.
CAPOX/SOX/FOLFOX	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Rongbo Lin; 🇨🇳 Fuzhou, China