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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Oxaliplatin; Paclitaxel

Criteria

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