Status:
UNKNOWN
A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Gastric Cancer Stage III
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 adenoca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03788226
Start Date
February 1 2019
End Date
December 31 2023
Last Update
October 16 2019
Active Locations (1)
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1
Rongbo Lin
Fuzhou, China, 350014