mFOLFOX Versus mFOLFIRI Versus FOLFPTX as First-line Treatment in AGC or EGJA

Sponsor
Fujian Cancer Hospital
Study ID
NCT03045770
Status
Unknown

Conditions

  • Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluorouracil — DRUG
    Fluorouracil was used as first line treatment with AGC.
  • Oxaliplatin — DRUG
    Oxaliplatin was used as first line treatment with AGC.
  • Irinotecan — DRUG
    Irinotecan was used as first line treatment with AGC.
  • Paclitaxel — DRUG
    Paclitaxel was used as first line treatment with AGC.
  • calcium levofolinate — DRUG
    Calcium levofolinate was used as first line treatment with AGC.

Study Details

The aim of this study was to compare the efficacy and safety of mFOLFOX, mFOLFIRI and FOLFPTX as first-line treatment in AGC or EGJA.

Key Dates

Start date
Feb 10, 2017
Status verified
Jan 2017
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mFOLFOX
    The mFOLFOX regimen consisted of oxaliplatin (85 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
  • Experimental: mFOLFIRI
    The mFOLFIRI regimen consisted of irinotecan (180 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
  • Experimental: FOLFPTX
    The FOLFPTX regimen consisted of paclitaxel (95 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 24 months ]

Central Contacts