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

Gastric Cancer Stage III Clinical Trial

Official title:

A Randomized Phase III Study Comparing POF (Paclitaxel/Oxaliplatin/Leucovorin/5-FU) With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788226
• Other study ID #: FNF 014
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2019
• Source: Fujian Cancer Hospital
• Contact: Rongbo Lin
• Phone: 13705919382
• Email: rongbo_lin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer Stage III
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Rongbo Lin	Fuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease-free survival	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	From enrollment to 5 years after treatment
Secondary	overall survival	The time from the date of randomisation to date of death from any cause	From enrollment to 5 years after treatment
Secondary	safety (The incidence of chemotherapy related adverse events)	The incidence of chemotherapy related adverse events	From enrollment to 1 years after treatment