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
  • End date
    Dec 31, 2023
  • participants needed
    600
  • sponsor
    Fujian Cancer Hospital
Updated on 7 February 2022

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).

Details
Condition Gastric Cancer Stage III
Treatment POF, Docetaxel/S-1, CAPOX/SOX/FOLFOX
Clinical Study IdentifierNCT03788226
SponsorFujian Cancer Hospital
Last Modified on7 February 2022

Eligibility

Yes No Not Sure

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
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