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

Last updated: October 13, 2019
Sponsor: Fujian Cancer Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT03788226
FNF 014
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 to 70 years.

  • Histologically proven in gastric adenocarcinoma (including adenocarcinoma of thegastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastaticdisease.

  • Subjects must be able to take orally.

  • R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examinedto 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

Exclusion Criteria:

  • Active double cancer

  • Gastrointestinal bleeding

  • Pregnancy or lactation women, or women with suspected pregnancy or men with willing toget pregnant

  • Definite contraindications for the use of corticosteroids

  • Any subject judged by the investigator to be unfit for any reason to participate inthe study

Study Design

Total Participants: 600
Study Start date:
February 01, 2019
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Rongbo Lin

    Fuzhou, 350014
    China

    Active - Recruiting

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